Chemosensitivity Testing to Assign Treatment for Patients With Stage III or Stage IV Ovarian Cancer
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Purpose
RATIONALE: Chemosensitizers may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: in vitro sensitivity-directed chemotherapy Drug: paclitaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III) |
| Estimated Enrollment: | 300 |
| Study Start Date: | July 1996 |
| Study Completion Date: | April 2000 |
| Primary Completion Date: | April 2000 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine whether the use of a chemosensitivity assay to assign treatment improves the time to progression and response rates of patients with stage III/IV ovarian cancer.
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.
Eligibility| Ages Eligible for Study: | up to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically/pathologically confirmed stage III and IV ovarian cancer Complete surgical staging and debulking including total abdominal hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and biopsies of suspicious lesions (if feasible) required No low malignant potential histology without any invasive lesions in the peritoneum
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
Contacts and Locations| Switzerland | |
| Kantonspital Aarau | |
| Aarau, Switzerland, 5001 | |
| Office of Walter Weber-Stadelman | |
| Basel, Switzerland, CH 4051 | |
| Frauenspital, Basel | |
| Basel, Switzerland, 4031 | |
| University Hospital | |
| Basel, Switzerland, CH-4031 | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| Hopital Cantonal Universitaire de Geneva | |
| Geneva, Switzerland, CH-1211 | |
| Istituto Oncologico della Svizzera Italiana | |
| Lugano, Switzerland, CH-6900 | |
| Burgerspital, Solothurn | |
| Solothurn, Switzerland, 4500 | |
| Klinik Hirslanden | |
| Zurich, Switzerland, CH-8008 | |
| City Hospital Triemli | |
| Zurich, Switzerland, 8063 | |
| Study Chair: | O.R. Kochli, MD | Frauenspital, Basel |
More Information
Publications:
| Responsible Party: | Swiss Group for Clinical Cancer Research |
| ClinicalTrials.gov Identifier: | NCT00003214 History of Changes |
| Other Study ID Numbers: | SAKK 45/94, SWS-SAKK-45/94, EU-97036 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 14, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Swiss Group for Clinical Cancer Research:
|
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Cisplatin Cyclophosphamide Doxorubicin Carboplatin |
Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antibiotics, Antineoplastic Tubulin Modulators |
ClinicalTrials.gov processed this record on June 17, 2013