Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-01-03 @ 5:50 AM
Study NCT ID:
NCT00003695
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], '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': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2001-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-03-12', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage II ovarian epithelial cancer', 'stage III ovarian epithelial cancer'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with surgery may kill more tumor cells. It is not yet known whether chemotherapy plus surgery is more effective than chemotherapy alone in treating patients with stage II or stage III ovarian cancer.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without surgery in treating patients with stage II or stage III ovarian cancer.', 'detailedDescription': 'OBJECTIVES: I. Determine the impact of interval debulking surgery, in terms of survival, disease-free survival, and quality of life, in patients with newly diagnosed stage II or III ovarian cancer and residual macroscopic disease greater than 1 cm after primary surgery.\n\nOUTLINE: This is a randomized study of debulking surgery with concurrent chemotherapy. Patients are randomized to receive chemotherapy alone (arm I) or chemotherapy and interval debulking surgery (arm II). Arm I: Patients receive six courses of platinum-based chemotherapy at intervals of 3 weeks. Arm II: Patients receive three courses of platinum-based chemotherapy at intervals of 3 weeks. In the absence of disease progression, patients undergo interval debulking surgery approximately 21 days after initiation of the third course of chemotherapy. Surgery is then immediately followed by three additional courses of platinum-based chemotherapy. Patients are followed at 6 months after randomization, then every 3 months for the remainder of the first 2 years, then every 6 months for the following 3 years, and then annually thereafter. Quality of life is assessed prior to randomization and before the fourth course of chemotherapy, and then at follow-up visits at 6 months and 1, 2, and 3 years.\n\nPROJECTED ACCRUAL: There will be 1,000 patients accrued into this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed stage II or III ovarian epithelial cancer Must be planning to receive platinum-based chemotherapy Must be fit for interval debulking surgery Residual macroscopic disease with longest dimension of largest tumor mass greater than 1 cm in diameter documented at primary surgery or postoperatively by imaging\n\nPATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No concurrent or prior malignancy likely to interfere with protocol treatments or comparison\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00003695', 'briefTitle': 'Chemotherapy With or Without Surgery in Treating Patients With Stage II or Stage III Ovarian Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomised Trial of Interval Debulking Surgery in Epithelial Ovarian Cancer Suboptimally Debulked at Primary Surgery', 'orgStudyIdInfo': {'id': 'CDR0000066799'}, 'secondaryIdInfos': [{'id': 'MRC-OV06'}, {'id': 'EU-98063'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'chemotherapy', 'type': 'DRUG'}, {'name': 'surgical procedure', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1A 7BE', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Saint Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ian Jacobs, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Elizabeth Garrett Anderson Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}}}}