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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003214 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III) |
Estimated Enrollment: | 300 |
Study Start Date: | July 1996 |
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
PROJECTED ACCRUAL: Approximately 300 patients will be accrued for this study over 6 years.
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
Switzerland | |
Burgerspital, Solothurn | |
Solothurn, Switzerland, 4500 | |
City Hospital Triemli | |
Zurich, Switzerland, 8063 | |
Frauenspital, Basel | |
Basel, Switzerland, 4031 | |
Hopital Cantonal Universitaire de Geneva | |
Geneva, Switzerland, CH-1211 | |
Inselspital, Bern | |
Bern, Switzerland, CH-3010 | |
University Hospital | |
Basel, Switzerland, CH-4031 | |
Kantonspital Aarau | |
Aarau, Switzerland, 5001 | |
Klinik Hirslanden | |
Zurich, Switzerland, CH-8008 | |
Office of Walter Weber-Stadelman | |
Basel, Switzerland, CH 4051 | |
Istituto Oncologico della Svizzera Italiana | |
Lugano, Switzerland, CH-6900 |
Study Chair: | O.R. Kochli, MD | Frauenspital, Basel |
Study ID Numbers: | CDR0000066074, SWS-SAKK-45/94, EU-97036 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003214 History of Changes |
Health Authority: | United States: Federal Government |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Immunologic Factors Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Cyclophosphamide Genital Diseases, Female Anti-Bacterial Agents Cisplatin Ovarian Cancer Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases Carboplatin Antimitotic Agents Ovarian Epithelial Cancer Immunosuppressive Agents Doxorubicin Carcinoma Paclitaxel Tubulin Modulators Endocrinopathy Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Ovarian Diseases Antibiotics, Antineoplastic Genital Diseases, Female Neoplasms by Site Therapeutic Uses Alkylating Agents Endocrine Gland Neoplasms Ovarian Neoplasms |
Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Carboplatin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Adnexal Diseases Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |