Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-27 @ 7:12 PM
Study NCT ID:
NCT01611766
Status:
UNKNOWN
Last Update Posted:
2021-06-10
First Post:
2012-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube 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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 356}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-07', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-06-04', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 60 months after last patient randomized', 'description': 'from date of randomisation until death'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to 24 months after last patient randomized', 'description': 'interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first'}], 'secondaryOutcomes': [{'measure': 'Accumulating Treatment-free survival (TFSa)', 'timeFrame': 'Up to 60 months after last patient randomized', 'description': 'the time of OS minus each treatment period after randomization, including surgery and chemotherapy'}, {'measure': 'Overall survival after the adjustment of one-way treatment switching', 'timeFrame': 'Up to 60 months after last patient randomized', 'description': 'OS adjusted by statistical models for crossover'}, {'measure': '30-day post-operative complications', 'timeFrame': 'From the operation until after 30 days', 'description': 'MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications'}, {'measure': 'Validation of iMODEL', 'timeFrame': 'From randomization to operation', 'description': 'iMODEL score to predict complete resection'}, {'measure': 'Patient compliance', 'timeFrame': 'Up to 60 months after last patient randomized', 'description': 'compliance with protocol'}, {'measure': 'Quality of life assessments', 'timeFrame': 'Study entry; 6 months; 12 months; 24 months and 60 months after randomization', 'description': 'The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O)'}, {'measure': 'Time to first subsequent anticancer therapy', 'timeFrame': 'Up to 60 months after last patient randomized', 'description': 'From date of randomization until the date of first recurrent anticancer therapy'}, {'measure': 'Time to second subsequent anticancer therapy', 'timeFrame': 'Up to 60 months after last patient randomized', 'description': 'From date of randomization until the date of secondary recurrent anticancer therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['secondary cytoreductive surgery', 'Ovarian Cancer', 'surgery', 'recurrence'], 'conditions': ['Ovarian Epithelial Cancer Recurrent', 'Fallopian Tube Carcinoma', 'Primary Peritoneal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '38824243', 'type': 'DERIVED', 'citation': 'Jiang R, Feng Y, Chen Y, Cheng X, Shi T, Gao W, Jia H, Jiang S, Guo Y, Huang X, Tu D, Zhang Y, Yang H, Zhang P, Liu J, Zhu J, Zang R; SOC-1 Investigators. Surgery versus no surgery in platinum-sensitive relapsed ovarian cancer: final overall survival analysis of the SOC-1 randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2181-2188. doi: 10.1038/s41591-024-02981-0. Epub 2024 Jun 1.'}, {'pmid': '33705695', 'type': 'DERIVED', 'citation': 'Shi T, Zhu J, Feng Y, Tu D, Zhang Y, Zhang P, Jia H, Huang X, Cai Y, Yin S, Jiang R, Tian W, Gao W, Liu J, Yang H, Cheng X, Zang R. Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):439-449. doi: 10.1016/S1470-2045(21)00006-1. Epub 2021 Mar 8.'}], 'seeAlsoLinks': [{'url': 'http://www.ShanghaiGOG.org', 'label': 'Shanghai Gynecologic Oncology Group'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer.', 'detailedDescription': 'The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at recurrence ≥ 18 years\n* Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with treatment -free interval of 6 months or more.\n* A complete secondary cytoreduction predicting score, iMODEL \\[Tian WJ, Ann Surg Oncol 2012,19(2):597-604\\]\\<=4.7, including FIGO stage (0 or 0.8); residual disease after primary surgery (0 or 1.5); Progression-free interval (0 or 2.4); PS ECOG (0 or 2.4); Ca125 (0 or 1.8); and ascites at recurrence (0 or 3.0). If PI and CO-PI reach consensus that the recurrent tumor detected by PET/CT could be completely resected, the index of CA125 could be scored as 0. (Revised on 09/30/2013)\n* Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. If single lesion outside the peritoneal cavity can be resected, MRI/CT or PET/CT scan should be performed to exclude simultaneous intra-abdominal lesions.\n* Patients who have given their signed and written informed consent and their consent.\n\nExclusion Criteria:\n\n* Patients with borderline tumors as well as non-epithelial tumors.\n* Patients for interval-debulking, or for second-look surgery, or palliative surgery planned.\n* Impossible to assess the resectability or evaluate the score. Radiological signs suggesting complete resection is impossible.\n* More than one prior chemotherapy.\n* Second relapse or more\n* Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.\n* Progression during chemotherapy or recurrence within 6 months after first-line therapy\n* Any contradiction not allowing surgery and/or chemotherapy\n\n 1. Accompanied by hypoxia serious chronic obstructive pulmonary disease\n 2. Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.\n 3. Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency\n 4. Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy.\n 5. Uncontrolled diabetes\n 6. Uncontrolled epilepsy need long-term antiepileptic treatment.\n* Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents, or bevacizumab.'}, 'identificationModule': {'nctId': 'NCT01611766', 'briefTitle': 'Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shanghai Gynecologic Oncology Group'}, 'officialTitle': 'Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial', 'orgStudyIdInfo': {'id': 'SGOG OV 2'}, 'secondaryIdInfos': [{'id': 'SGOG OV2', 'type': 'OTHER', 'domain': 'SGOG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'secondary cytoreductive surgery', 'description': 'SCR followed by chemotherapy', 'interventionNames': ['Procedure: Secondary Cytoreductive Surgery', 'Drug: Salvage Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Salvage Chemotherapy', 'description': 'platinum-based chemotherapy', 'interventionNames': ['Drug: Salvage Chemotherapy']}], 'interventions': [{'name': 'Secondary Cytoreductive Surgery', 'type': 'PROCEDURE', 'otherNames': ['Maximum effort cytoreductive surgery'], 'description': 'Complete Cytoreduction', 'armGroupLabels': ['secondary cytoreductive surgery']}, {'name': 'Salvage Chemotherapy', 'type': 'DRUG', 'otherNames': ['second line chemotherapy'], 'description': '6 cycles of postoperative chemotherapy', 'armGroupLabels': ['Salvage Chemotherapy', 'secondary cytoreductive surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Rongyu Zang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Gynecologic Oncology Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Gynecologic Oncology Group', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}