Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-03-15 @ 9:23 AM
Study NCT ID:
NCT01341756
Status:
UNKNOWN
Last Update Posted:
2011-05-09
First Post:
2011-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-06', 'studyFirstSubmitDate': '2011-04-18', 'studyFirstSubmitQcDate': '2011-04-24', 'lastUpdatePostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response of bleeding to radiotherapy', 'timeFrame': 'At the 12th fraction of radiotherapy and at one month post radiotherapy', 'description': 'Percentage of patients who do not require blood transfusion after radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0', 'timeFrame': 'within the first 14 days from start of radiotherapy', 'description': 'Toxicity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Radiotherapy', 'palliation', 'bleeding', 'pain', 'obstruction'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '30790469', 'type': 'DERIVED', 'citation': 'Tey J, Zheng H, Soon YY, Leong CN, Koh WY, Lim K, So JBY, Shabbir A, Tham IWK, Lu J. Palliative radiotherapy in symptomatic locally advanced gastric cancer: A phase II trial. Cancer Med. 2019 Apr;8(4):1447-1458. doi: 10.1002/cam4.2021. Epub 2019 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls.', 'detailedDescription': 'The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls. (Tey et al.) With this dose fractionation is used for bleeding, there is an increase in response rates from 55%(historical) to 75%for pain, there is an increase in response rates from 25% (historical) to 45% for obstruction, there is an increase in response rates from 25% (historical) to 45%'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven adenocarcinoma of the stomach\n* Treated with palliative intent\n* At least one index symptom such as bleeding, obstruction or pain\n* No prior abdominal radiotherapy\n* Not on chemotherapy\n\nExclusion Criteria:\n\n* Patients treated with radical intent\n* Previous abdominal radiotherapy\n* Patients on chemotherapy'}, 'identificationModule': {'nctId': 'NCT01341756', 'briefTitle': 'Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial', 'orgStudyIdInfo': {'id': 'B/09/134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy for gastric cancer', 'description': 'Single arm study', 'interventionNames': ['Radiation: Palliative Radiotherapy']}], 'interventions': [{'name': 'Palliative Radiotherapy', 'type': 'RADIATION', 'otherNames': ['palliation, radiotherapy'], 'description': 'Palliative Radiotherapy to a total dose of 36Gy in 12 fractions', 'armGroupLabels': ['Radiotherapy for gastric cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'state': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Jeremy Tey, FRANZCR', 'role': 'CONTACT', 'email': 'jeremy_Tey@nuhs.edu.sg', 'phone': '+65 67724869'}, {'name': 'Jeremy Tey, FRANZCR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Jeremy Tey, FRANZCR', 'role': 'CONTACT', 'email': 'jeremy_tey@nuhs.edu.sg', 'phone': '+65 67724869'}], 'overallOfficials': [{'name': 'Jeremy Tey, FRANZCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tan Tock Seng Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jeremy Tey', 'oldOrganization': 'National University Hospital'}}}}