Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT02638051
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2015-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010534', 'term': 'Peritoneal Neoplasms'}, {'id': 'D001201', 'term': 'Ascites'}, {'id': 'D016711', 'term': 'Yang Deficiency'}, {'id': 'D016710', 'term': 'Yin Deficiency'}], 'ancestors': [{'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cpang@cliffordgroup.com', 'phone': '(8620) 34710038', 'title': 'Prof. Clifford LK Pang, President of Clifford Hospital', 'organization': 'Clifford Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '* Absence of the detailed peritoneal carcinomatosis characteristics.\n* Absence of a survival analysis. These limitations are related to the restricted funding of the trial.'}}, 'adverseEventsModule': {'timeFrame': '2 months', 'description': 'The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".', 'eventGroups': [{'id': 'EG000', 'title': 'Study Group', 'description': 'Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.\n\nModulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.\n\nTCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.', 'otherNumAtRisk': 130, 'otherNumAffected': 3, 'seriousNumAtRisk': 130, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.\n\nIPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).', 'otherNumAtRisk': 130, 'otherNumAffected': 16, 'seriousNumAtRisk': 130, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bone marow depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gastrointestinal Reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Damage of hepatic function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Damage of renal function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.\n\nModulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.\n\nTCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.\n\nIPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).'}], 'classes': [{'categories': [{'measurements': [{'value': '77.7', 'groupId': 'OG000'}, {'value': '63.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0140', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Applies to "Objective Response Rate (ORR)"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks after start of treatment (4 weeks on completion of treatment)', 'description': 'Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR)\n\nWHO criteria of therapeutic effect evaluation at malignant ascites:\n\n* Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month.\n* Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month.\n* No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events Rate (AER)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.\n\nModulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.\n\nTCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.\n\nIPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).'}], 'classes': [{'title': 'All', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal pain (Gr. I)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal Reactions (Gr. I)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Damage of hepatic or renal function (Gr. I)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bone marrow depression (Gr. I)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Applies to "All" Adverse Events rate', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Applies to "Abdominal pain" rate', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Applies to "Gastrointestinal reactions"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Applies to "Damage of hepatic or renal function"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0215', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Applies to "Bone marrow depression"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'During 4 weeks of treatment course and 4 weeks after treatment', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group', 'description': 'Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.\n\nModulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.\n\nTCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.\n\nIPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).'}], 'classes': [{'title': 'Better QoL (KPS IR)', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '32.3', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}, {'value': '52.3', 'groupId': 'OG001'}]}]}, {'title': 'Worse QoL', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0053', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Applies to "Better QoL"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0527', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Applies to "No Change"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Applies to "Worse QoL"', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks after start of treatment (4 weeks on completion of treatment)', 'description': 'Karnofsky Performance Score Improvement Rate (KPS IR)\n\n* Improvement: increase of KPS for ≥10% after treatment.\n* Worsening: reduction of KPS for ≥10% after treatment.\n* NC: change of KPS for \\<10%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Group', 'description': 'Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.\n\nModulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.\n\nTCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter was occluded. Administered biweekly during four weeks of the course, totally two times.\n\nIPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From January 3, 2014 to December 20, 2014, 260 patients were recruited in Clifford Hospital. They were randomly allocated in two groups with 130 patients in each group.', 'preAssignmentDetails': 'There was no any pre-assignment dropout or exclusion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Group', 'description': 'Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.\n\nModulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.\n\nTCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.\n\nIPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.88', 'spread': '12.43', 'groupId': 'BG000'}, {'value': '56.07', 'spread': '15.38', 'groupId': 'BG001'}, {'value': '57.48', 'spread': '14.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary Disease', 'classes': [{'title': 'Gastric Cancer', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Colon Cancer', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Rectal Cancer', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Pancreatic Cancer', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Endometrial Cancer', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Ovarian Cancer', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Liver Cancer', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Metastases', 'classes': [{'title': 'Lungs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Celiac lymph nodes', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Bones', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stage', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Peritoneal carcinomatosis itself is considered III stage; evidence of distant metastases means IV stage.', 'unitOfMeasure': 'participants'}, {'title': 'Karnofsky Performance Score', 'classes': [{'title': '60', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': '70', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': '80', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': '90', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'KPS 90% - symptomatic patients with normal daily activity. KPS 80% - normal daily activity with effort. KPS 70% - limited daily activity (unable to work), complete self-care. KPS 60% - limited daily activity (unable to work), limited self-care (needs assistance), active \\>50% of daytime.\n\nKPS \\<60% (Perforce inactive (sits or lies) ≥50% of daytime) excluded.', 'unitOfMeasure': 'participants'}, {'title': 'CDDP (Intraperitoneal Chemoinfusion) Dose Per Session', 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000'}, {'value': '49.63', 'spread': '10.19', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'CDDP applied in Control Group only, total result is not applicable', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '5-FU (Intraperitoneal Chemoinfusion) Dose Per Session', 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000'}, {'value': '548.5', 'spread': '39.68', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': '5FU applied in Control Group only, total result is not applicable', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/sqm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Interventions', 'classes': [{'title': 'mEHT', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': 'NA', 'comment': 'mEHT applied in Study Group only, total result is not applicable', 'groupId': 'BG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'TCM', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '28'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': 'NA', 'comment': 'TCM applied in Study Group only, total result is not applicable', 'groupId': 'BG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'IPCI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': 'NA', 'comment': 'IPCI applied in Control Group only, total result is not applicable', 'groupId': 'BG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'sessions', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-15', 'studyFirstSubmitDate': '2015-12-17', 'resultsFirstSubmitDate': '2015-12-23', 'studyFirstSubmitQcDate': '2015-12-18', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-02', 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '8 weeks after start of treatment (4 weeks on completion of treatment)', 'description': 'Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR)\n\nWHO criteria of therapeutic effect evaluation at malignant ascites:\n\n* Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month.\n* Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month.\n* No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events Rate (AER)', 'timeFrame': 'During 4 weeks of treatment course and 4 weeks after treatment', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute.'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': '8 weeks after start of treatment (4 weeks on completion of treatment)', 'description': 'Karnofsky Performance Score Improvement Rate (KPS IR)\n\n* Improvement: increase of KPS for ≥10% after treatment.\n* Worsening: reduction of KPS for ≥10% after treatment.\n* NC: change of KPS for \\<10%.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peritoneal Carcinomatosis', 'Malignant Ascites', 'Modulated Electro-Hyperthermia', 'Traditional Chinese Medicine'], 'conditions': ['Peritoneal Neoplasms', 'Ascites', 'Yang Deficiency', 'Yin Deficiency']}, 'referencesModule': {'availIpds': [{'id': '10.3892/mco.2017.1221', 'url': 'https://www.spandidos-publications.com/mco/6/5/723?articleTypes=ARTICLE&articleTypes=REVIEW&fileTypes=LETTER_TO_THE_EDITOR&fileTypes=MANUSCRIPT&fileTypes=TABLE&fileTypes=IMAGE&fileTypes=LANG_EDIT', 'type': 'Clinical Study Report', 'comment': 'Pang CLK, Zhang X, Wang Z, Ou J, Lu Y, Chen P, Zhao C, Wang X, Zhang H, Roussakow SV. Local modulated electro-hyperthermia in combination with traditional Chinese medicine vs. intraperitoneal chemoinfusion for the treatment of peritoneal carcinomatosis with malignant ascites: A phase II randomized trial. Mol Clin Oncol. 2017;6:723-32,'}], 'references': [{'pmid': '22590662', 'type': 'BACKGROUND', 'citation': 'Sangisetty SL, Miner TJ. Malignant ascites: A review of prognostic factors, pathophysiology and therapeutic measures. World J Gastrointest Surg. 2012 Apr 27;4(4):87-95. doi: 10.4240/wjgs.v4.i4.87.'}, {'pmid': '19240999', 'type': 'BACKGROUND', 'citation': 'Andocs G, Renner H, Balogh L, Fonyad L, Jakab C, Szasz A. Strong synergy of heat and modulated electromagnetic field in tumor cell killing. Strahlenther Onkol. 2009 Feb;185(2):120-6. doi: 10.1007/s00066-009-1903-1. Epub 2009 Feb 25.'}, {'pmid': '24562547', 'type': 'BACKGROUND', 'citation': 'Meggyeshazi N, Andocs G, Balogh L, Balla P, Kiszner G, Teleki I, Jeney A, Krenacs T. DNA fragmentation and caspase-independent programmed cell death by modulated electrohyperthermia. Strahlenther Onkol. 2014 Sep;190(9):815-22. doi: 10.1007/s00066-014-0617-1. Epub 2014 Feb 22.'}, {'pmid': '25842096', 'type': 'BACKGROUND', 'citation': 'Ling Y. Traditional Chinese medicine in the treatment of symptoms in patients with advanced cancer. Ann Palliat Med. 2013 Jul;2(3):141-52. doi: 10.3978/j.issn.2224-5820.2013.04.05.'}, {'pmid': '24973890', 'type': 'BACKGROUND', 'citation': 'Andocs G, Meggyeshazi N, Balogh L, Spisak S, Maros ME, Balla P, Kiszner G, Teleki I, Kovago C, Krenacs T. Upregulation of heat shock proteins and the promotion of damage-associated molecular pattern signals in a colorectal cancer model by modulated electrohyperthermia. Cell Stress Chaperones. 2015 Jan;20(1):37-46. doi: 10.1007/s12192-014-0523-6. Epub 2014 Jun 29.'}, {'pmid': '26472466', 'type': 'BACKGROUND', 'citation': 'Tsang YW, Huang CC, Yang KL, Chi MS, Chiang HC, Wang YS, Andocs G, Szasz A, Li WT, Chi KH. Improving immunological tumor microenvironment using electro-hyperthermia followed by dendritic cell immunotherapy. BMC Cancer. 2015 Oct 15;15:708. doi: 10.1186/s12885-015-1690-2.'}, {'pmid': '21644239', 'type': 'BACKGROUND', 'citation': 'Matharu G, Tucker O, Alderson D. Systematic review of intraperitoneal chemotherapy for gastric cancer. Br J Surg. 2011 Sep;98(9):1225-35. doi: 10.1002/bjs.7586. Epub 2011 Jun 6.'}, {'pmid': '28529748', 'type': 'RESULT', 'citation': 'Pang CLK, Zhang X, Wang Z, Ou J, Lu Y, Chen P, Zhao C, Wang X, Zhang H, Roussakow SV. Local modulated electro-hyperthermia in combination with traditional Chinese medicine vs. intraperitoneal chemoinfusion for the treatment of peritoneal carcinomatosis with malignant ascites: A phase II randomized trial. Mol Clin Oncol. 2017 May;6(5):723-732. doi: 10.3892/mco.2017.1221. Epub 2017 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'This trial studies efficacy and safety of combination of modulated electro-hyperthermia (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with malignant ascites versus standard chemoinfusion (CDDP+5FU).', 'detailedDescription': 'Conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) is based on chemoinfusion with its inherent toxicity. There is a strong demand for a safe and non-toxic method of treatment of PCMA. The new technology of modulated electro-hyperthermia (mEHT) has proven efficacy in many advanced cancers with minimal side effects and synergy with Traditional Chinese Medicine (TCM). TCM has a long history of application at advanced cancer as a symptomatic treatment and enhancer of the general resistance of the organism. Shi Pi Decoction is supposed to be the optimum co-treatment of PCMA according to principles of TCM. Intraperitoneal chemoinfusion (IPCI) with cisplatin and fluorouracil is a widespread standard treatment of PCMA in China. This randomized II phase trial studies efficacy and safety of combination of mEHT with TCM in treatment of PCMA versus standard IPCI (CDDP+5FU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed PC with malignant ascites.\n* Karnofsky Performance Status (KPS) score ≥60%.\n* Normal function of bone marrow.\n* Predicted survival time \\>1 month.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Surgery within 3 weeks or not full recovery of postoperative suture.\n* Active bleeding or vascular occlusion in the mEHT treatment area.\n* Emotional instability.\n* Impossibility to place the patient into the mEHT machine.\n* Metallic implants or replacements in the treatment area.\n* Electronic implanted devices anywhere.\n* Missing or damaged heat-sense nerves or other field-sensitive issues in the treatment area.\n* Very low white blood cell count (\\<1.5×10(9)/L), agranulocytosis (\\<0.5×10(9)/L) or severe anemia.'}, 'identificationModule': {'nctId': 'NCT02638051', 'acronym': 'OTMA-RII', 'briefTitle': 'Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT', 'organization': {'class': 'OTHER', 'fullName': 'Galenic Research Institute Ltd'}, 'officialTitle': 'Local Modulated Electro-Hyperthermia in Combination With Traditional Chinese Medicine Versus Intraperitoneal Chemoinfusion in Treatment of Peritoneal Carcinomatosis With Malignant Ascites: A Phase II Randomized Trial', 'orgStudyIdInfo': {'id': 'OT-CH-PCMA-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.', 'interventionNames': ['Device: Modulated Electro-Hyperthermia (mEHT)', 'Dietary Supplement: TCM Herbal Decoction (Shi Pi)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.', 'interventionNames': ['Drug: IPCI (CDDP+5FU)']}], 'interventions': [{'name': 'Modulated Electro-Hyperthermia (mEHT)', 'type': 'DEVICE', 'otherNames': ['Oncothermia'], 'description': 'MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.', 'armGroupLabels': ['Study Group']}, {'name': 'TCM Herbal Decoction (Shi Pi)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Shi Pi Decoction'], 'description': 'Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.', 'armGroupLabels': ['Study Group']}, {'name': 'IPCI (CDDP+5FU)', 'type': 'DRUG', 'description': 'Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '511495', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Clifford Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Clifford LK Pang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clifford Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galenic Research Institute Ltd', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}