Chemosensitivity Testing to Assign Treatment for Patients With Stage III or Stage IV Ovarian Cancer
NCT ID: NCT00003214
Last Updated: 2019-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
1996-07-31
2000-04-30
Brief Summary
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PURPOSE: Randomized phase III trial to study the effectiveness of chemosensitivity testing to assign treatment for patients with stage III or stage IV ovarian cancer who have undergone surgery.
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Detailed Description
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OUTLINE: This is a randomized study. Patients are stratified according to size of tumor after debulking surgery, stage, and Swiss Group for Clinical Cancer Research center where treatment is received. Within 14 days after patients undergo debulking surgery, they are randomized to one of two treatment arms. Arm I: Patients randomized to this arm receive one of six treatment regimens: Regimen A - cisplatin/cyclophosphamide Regimen B - cisplatin/cyclophosphamide/doxorubicin Regimen C - carboplatin Regimen D - carboplatin/cyclophosphamide Regimen E - cisplatin/paclitaxel Regimen F - carboplatin/paclitaxel Arm II: Patients who are randomized to this arm are assigned a treatment regimen based on a chemosensitivity assay of tumor specimens collected after debulking surgery. If no valid assay result is obtained, patients receive carboplatin/cyclophosphamide. Treatment is repeated every 3-4 weeks for a total of 6 courses. Up to 4 more courses may be administered if a partial response is demonstrated. Patients are followed every 3 months for the first 2 years and every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 300 patients will be accrued for this study over 6 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carboplatin
cisplatin
cyclophosphamide
doxorubicin hydrochloride
in vitro sensitivity-directed chemotherapy
paclitaxel
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 80 and under Performance status: 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No disorder that would prevent the application of any protocol treatment
PRIOR CONCURRENT THERAPY: See Disease Characteristics
80 Years
FEMALE
No
Sponsors
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Swiss Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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O.R. Kochli, MD
Role: STUDY_CHAIR
Frauenspital, Basel
Locations
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Kantonspital Aarau
Aarau, , Switzerland
Frauenspital, Basel
Basel, , Switzerland
Office of Walter Weber-Stadelman
Basel, , Switzerland
University Hospital
Basel, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Hopital Cantonal Universitaire de Geneva
Geneva, , Switzerland
Istituto Oncologico della Svizzera Italiana
Lugano, , Switzerland
Burgerspital, Solothurn
Solothurn, , Switzerland
City Hospital Triemli
Zurich, , Switzerland
Klinik Hirslanden
Zurich, , Switzerland
Countries
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References
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Koechli OR, Delaloye JF, Maibach R, et al.: Ovarian carcinoma FIGO II and IV - results of a randomized multicenter feasibility study with the ATP cell viability chemosensitivity assay. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-1326, 1997.
Mariotta M, Perewusnyk G, Koechli OR, Little JB, von Knebel Doeberitz M, Mirimanoff RO, Rutz HP. Dexamethasone-induced enhancement of resistance to ionizing radiation and chemotherapeutic agents in human tumor cells. Strahlenther Onkol. 1999 Aug;175(8):392-6. doi: 10.1007/s000660050027.
Other Identifiers
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SWS-SAKK-45/94
Identifier Type: -
Identifier Source: secondary_id
EU-97036
Identifier Type: -
Identifier Source: secondary_id
SAKK 45/94
Identifier Type: -
Identifier Source: org_study_id
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