Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT05200260
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2022-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D000067856', 'term': 'Poly(ADP-ribose) Polymerase Inhibitors'}, {'id': 'C531550', 'term': 'olaparib'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2022-01-17', 'studyFirstSubmitQcDate': '2022-01-17', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year overall survival', 'timeFrame': 'Participants will be followed for at least 3 years after randomization', 'description': 'The proportion of patients alive at 3 years after entry into the study'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Participants will be followed for at least 3 years after randomization', 'description': 'Time from entry into the study to any cause of death'}, {'measure': 'Progression-free survival', 'timeFrame': 'Participants will be followed for at least 3 years after randomization', 'description': 'Time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first'}, {'measure': 'Post-operative complications', 'timeFrame': 'Participants will be followed up to 3 months after randomization', 'description': 'The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery'}, {'measure': 'Quality of life assessments', 'timeFrame': 'Participants will be followed for at least 3 years after randomization', 'description': 'QLQ-C30, FACT-Q (baseline; 6 months, 12 months, 24 months and 36 months after randomization)'}, {'measure': 'Accumulated treatment-free survival', 'timeFrame': 'Participants will be followed for at least 3 years or death after randomization', 'description': 'Time from the date of randomization to death from any reason, minus the total treatment time of surgery and chemotherapy after randomization (regardless of targeted therapy)'}, {'measure': 'TFST', 'timeFrame': 'Participants will be followed for at least 3 years or death after randomization', 'description': 'Time from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first'}, {'measure': 'TSST', 'timeFrame': 'Participants will be followed for at least 3 years or death after randomization', 'description': 'Time from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurred first'}, {'measure': 'The pattern of the first relapse', 'timeFrame': 'Participants will be followed for at least 3 years or death after randomization', 'description': 'The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ovarian Cancer', 'Primary Debulking Surgery', 'Neoadjuvant chemotherapy', 'Poly-adenosine Ribose Phosphate Inhbitors (PARPi)', 'Bevacizumab'], 'conditions': ['Ovarian Cancer', 'Fallopian Tube Cancer', 'Primary Peritoneal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer', 'detailedDescription': "The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Bevacizumab or Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females aged ≥ 18 years.\n* Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma\n* Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination\n* Complete cytoreduction can be achieved based on CT or PET/CT examination\n* Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing\n* Performance status (ECOG 0-2)\n* Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:\n\n 1. white blood cells \\>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,\n 2. serum creatinine \\<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,\n 3. serum bilirubin \\<1.25 x UNL, AST(SGOT) and ALT(SGPT) \\<2.5 x UNL.\n* Comply with the study protocol and follow-up.\n* Patients who have given their written informed consent.\n\nExclusion Criteria:\n\n* Non-epithelial ovarian malignancies and borderline tumors\n* Low grade ovarian cancer\n* Mucinous ovarian cancer\n* Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases\n* Patient has a known hypersensitivity to the components of olaparib/bevacizumab or its excipients\n* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).\n* Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.\n* Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.'}, 'identificationModule': {'nctId': 'NCT05200260', 'briefTitle': 'Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shanghai Gynecologic Oncology Group'}, 'officialTitle': 'A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer', 'orgStudyIdInfo': {'id': 'SAT-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Upfront cytoreductive surgery with maintenance therapy', 'description': 'Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).', 'interventionNames': ['Procedure: Primary debulking surgery', 'Drug: PARP inhibitor', 'Drug: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neoadjuvant chemotherapy with maintenance therapy', 'description': 'Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).', 'interventionNames': ['Procedure: Neoadjuvant chemotherapy', 'Drug: PARP inhibitor', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Primary debulking surgery', 'type': 'PROCEDURE', 'otherNames': ['PDS'], 'description': 'Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.', 'armGroupLabels': ['Upfront cytoreductive surgery with maintenance therapy']}, {'name': 'Neoadjuvant chemotherapy', 'type': 'PROCEDURE', 'otherNames': ['Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS'], 'description': '3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.', 'armGroupLabels': ['Neoadjuvant chemotherapy with maintenance therapy']}, {'name': 'PARP inhibitor', 'type': 'DRUG', 'otherNames': ['Olaparib'], 'description': 'For patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy.', 'armGroupLabels': ['Neoadjuvant chemotherapy with maintenance therapy', 'Upfront cytoreductive surgery with maintenance therapy']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy.', 'armGroupLabels': ['Neoadjuvant chemotherapy with maintenance therapy', 'Upfront cytoreductive surgery with maintenance therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Foshan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Songhua Yuan', 'role': 'CONTACT', 'email': 'yuan-sh09@163.com'}], 'facility': "The First People's Hospital of Foshan", 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuyao Zhang', 'role': 'CONTACT', 'email': 'zhangchy@sysucc.org.cn'}], 'facility': 'Sun Yet-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianhua Qian', 'role': 'CONTACT', 'email': 'qianjianhua@zju.edu.cn'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingli Zhang', 'role': 'CONTACT', 'email': 'zhangyl@zjcc.org.cn'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hefei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Zhou', 'role': 'CONTACT', 'email': 'caddiezy@ustc.edu.cn'}], 'facility': 'The First Affiliated Hospital of University of Science and Technology of China', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huijuan Yang', 'role': 'CONTACT', 'email': 'huijuanyang@hotmail.com'}], 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Jiang', 'role': 'CONTACT', 'email': 'jiangwei1436@fckyy.org.cn'}], 'facility': 'Obstetrics and Gynecology Hospital of Fundan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xipeng Wang', 'role': 'CONTACT', 'email': 'xipengwang@hotmail.com'}], 'facility': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Libing Xiang', 'role': 'CONTACT', 'email': 'xiang.libing@zs-hospital.sh.cn', 'phone': '862164041990', 'phoneExt': '2801'}, {'name': 'Libing Xiang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Libing Xiang', 'role': 'CONTACT', 'email': 'xiang.libing@zs-hospital.sh.cn', 'phone': '86 21 64041990', 'phoneExt': '2801'}, {'name': 'Rong Jiang', 'role': 'CONTACT', 'email': 'jiang.rong@zs-hospital.sh.cn', 'phone': '86 21 64041990', 'phoneExt': '2801'}], 'overallOfficials': [{'name': 'Libing Xiang', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Gynecologic Oncology Group', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}