Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-20 @ 4:43 PM
Study NCT ID:
NCT03373058
Status:
UNKNOWN
Last Update Posted:
2019-11-06
First Post:
2017-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000084262', 'term': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'id': 'D065426', 'term': 'Cytoreduction Surgical Procedures'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 310}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median recurrence-free survival', 'timeFrame': '3 years', 'description': 'assess median recurrence-free survival during 3 years in both study arms'}], 'secondaryOutcomes': [{'measure': 'Median overall survival', 'timeFrame': '3 years', 'description': 'assess median overall survival during 3 years in both study arms'}, {'measure': 'Median progression-free survival', 'timeFrame': '3 years', 'description': 'assess median progression-free survival during 3 years in both study arms'}, {'measure': 'Risk factors for morbidity and mortality', 'timeFrame': '30 days; 3 years', 'description': 'The early complication and mortality are defined as the event observed within 30 days after intervention, while the time frame for late complication is the period beyond 30 days after intervention to the end of 3 years. Complications are ranked from grade 0-5 according to CTCAE V4.0'}, {'measure': 'Quality of life for ovarian cancer', 'timeFrame': '3 years', 'description': 'Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperthermic Intraperitoneal Chemotherapy', 'Advanced-Stage Epithelial Ovarian Cancer', 'Cytoreductive surgery', 'Postoperative Chemotherapy'], 'conditions': ['Epithelial Ovarian Cancer', 'Fallopian Tube Cancer', 'Primary Peritoneal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free survival is the primary end points of this project.', 'detailedDescription': 'The current standard treatment for epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by intravenous chemotherapy with or without intraperitoneal chemotherapy (IP). Recently, the organizations of SGO and ASCO recommended that women with Fagotti score by laparoscopic exploration \\< 6 would benefit from primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to attain optimal cytoreduction (residual lesion ≤ 1 cm).\n\nHyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as newly postoperative chemotherapy after primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III )\n* Fagotti score by laparoscopic exploration \\< 6\n* Residual tumor \\< 1cm after completion of cytoreductive surgery\n* 18 \\< Age \\< 70 year old\n* Expected survival \\> 3 months\n* Performance status: ECOG 0-1\n* Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3\n* Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L\n* Voluntary participation after getting written informed consent.\n\nExclusion Criteria:\n\n* Fagotti score by laparoscopic exploration \\>= 6\n* Suboptimal debulking (residual tumor \\> 1cm)\n* Extensive adhesion in peritoneal cavity\n* Previous History of other malignancies (except excision of skin cancer, thyroid cancer)\n* Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\\<50%\n* Receiving other chemotherapy, radiotherapy or immunotherapy\n* Patients who are unsuitable candidates by doctor's decision\n* Without given written informed consent"}, 'identificationModule': {'nctId': 'NCT03373058', 'acronym': 'EHTASEOCCS', 'briefTitle': 'Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University'}, 'officialTitle': 'A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery', 'orgStudyIdInfo': {'id': 'HIPEC-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': '1. Cytoreductive surgery\n2. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m\\^2 and cisplatin 75 mg/m\\^2 intraperitoneally in succession\n3. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\\^2 IV\\>3 hour(Docetaxel 75 mg/m\\^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV\\>1 hour, every 3 weeks.', 'interventionNames': ['Procedure: Hyperthermic Intraperitoneal Chemotherapy', 'Procedure: cytoreductive surgery', 'Drug: adjuvant chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '1. Cytoreductive surgery\n2. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m\\^2 IV\\>3 hour(Docetaxel 75 mg/m\\^2, if paclitaxel is not available)+ carboplatin AUC = 5-6 IV\\>1 hour, every 3 weeks.', 'interventionNames': ['Procedure: cytoreductive surgery', 'Drug: adjuvant chemotherapy']}], 'interventions': [{'name': 'Hyperthermic Intraperitoneal Chemotherapy', 'type': 'PROCEDURE', 'otherNames': ['HIPEC'], 'description': 'HIPEC is performed as postoperative chemotherapy after cytoreductive surgery for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 48h after cytoreductive surgery: Paclitaxel 175 mg/m\\^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The HIPEC regimens are Docetaxel 75 mg/m\\^2 and cisplatin 75 mg/m\\^2, respectively, 43°C, 90min.', 'armGroupLabels': ['Experimental group']}, {'name': 'cytoreductive surgery', 'type': 'PROCEDURE', 'otherNames': ['CRS'], 'description': 'Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'adjuvant chemotherapy', 'type': 'DRUG', 'otherNames': ['ACT'], 'description': 'Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m\\^2 IV\\>3 hour+ carboplatin AUC = 5-6 IV\\>1 hour, every 3 weeks for 2 cycles in experimental group.\n\nSystemic chemotherapy regimens after IDS are paclitaxel 175 mg/m\\^2 IV\\>3 hour+ carboplatin AUC = 5-6 IV\\>1 hour, every 3 weeks for 3 cycles in control group.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510095', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'shuzhong cui, M.D', 'role': 'CONTACT', 'email': 'cuishuzhong@126.com', 'phone': '0086-138-0251-3800'}, {'name': 'Zhen Tang, M.M', 'role': 'CONTACT', 'email': '57932181@qq.com', 'phone': '0086-159-2081-9128'}, {'name': 'shuzhong cui, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Tumor Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510235', 'city': 'Guanzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongqiu Lin, MD', 'role': 'CONTACT', 'email': 'lin-zhongqiu@163.com', 'phone': '08613802921545'}, {'name': 'Jing Li, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sun Yat-sen Memorial Hospital,Sun Yat-sen University', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunong Gao, MD', 'role': 'CONTACT', 'phone': '010-88196216'}, {'name': 'Qian Li, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Zhou, MD', 'role': 'CONTACT', 'email': 'qizhou9128@163.com'}, {'name': 'Xingtao Long, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chongqing Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junying Tang, MD', 'role': 'CONTACT', 'email': 'tangjy_cqmu@sina.com'}, {'name': 'Lin Xiao, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'LI Hong, MD', 'role': 'CONTACT', 'email': '1072247562@qq.com'}], 'facility': 'Hubei General Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Wang, MD', 'role': 'CONTACT'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Shuzhong Cui, M.D', 'role': 'CONTACT', 'email': 'cuishuzhong@126.com', 'phone': '0086-138-0251-3800'}, {'name': 'Xian-Zi Yang, M.D', 'role': 'CONTACT', 'email': '7097359@qq.com', 'phone': '0086-188-9853-4167'}], 'overallOfficials': [{'name': 'Shuzhong Cui, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University'}, {'name': 'Zhongqiu Lin, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'The Third Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': "Peking University People's Hospital", 'class': 'OTHER'}, {'name': 'Cancer Hospital of Guizhou Province', 'class': 'OTHER'}, {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'Hebei Medical University Fourth Hospital', 'class': 'OTHER'}, {'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': 'West China Second University Hospital', 'class': 'OTHER'}, {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, {'name': 'The Third Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'Wuhan University', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Obstetrics & Gynecology Hospital of Fudan University', 'class': 'OTHER'}, {'name': 'Southern Medical University, China', 'class': 'OTHER'}, {'name': 'Fourth Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Shandong Cancer Hospital and Institute', 'class': 'OTHER'}, {'name': 'Beijing Obstetrics and Gynecology Hospital', 'class': 'OTHER'}, {'name': 'Chongqing University Cancer Hospital', 'class': 'OTHER'}, {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, {'name': 'Affiliated Cancer Hospital of Shantou University Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}