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Spots Global Cancer Trial Database for High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery

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Trial Identification

Brief Title: High-Dose Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer That Has Been Removed During Surgery

Official Title: A Randomized Phase III Trial of Sequential High Dose Chemotherapy or Standard Chemotherapy for Optimally Debulked FIGO Stage III and IV Ovarian Cancer

Study ID: NCT00004921

Conditions

Ovarian Cancer

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for ovarian epithelial cancer. PURPOSE: This randomized phase III trial is studying high-dose chemotherapy to see how well it works compared to standard chemotherapy in treating patients with stage III or stage IV ovarian epithelial cancer that has been removed during surgery.

Detailed Description: OBJECTIVES: * Compare the two-year progression-free survival in patients with optimally debulked stage III or IV ovarian epithelial cancer undergoing high-dose sequential chemotherapy vs standard chemotherapy. * Compare the overall survival, toxicity, and quality of life in this patient population receiving these two treatment regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive 5 courses of sequential high-dose chemotherapy as follows: * Courses 1 and 2: Patients receive paclitaxel IV over 3 hours and cyclophosphamide IV over 2 hours on day 1 followed by peripheral blood stem cell (PBSC) collection. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours following chemotherapy and continuing until target number of PBSC are reached. * Courses 3 and 4: Patients receive paclitaxel as in courses 1-2 and carboplatin IV over 4 hours on day 1. At 72 hours following completion of carboplatin, patients receive PBSC infusion. Beginning one day following PBSC infusion, patients receive G-CSF SC until blood counts recover. * Course 5: Patients receive paclitaxel as in courses 1 and 2 and carboplatin as in courses 3 and 4 and melphalan IV over 15 minutes on day 2 or 3. Patients receive PBSC and G-CSF as in courses 3 and 4. * Treatment repeats every 3-4 weeks. * Arm II: Patients receive standard chemotherapy consisting of carboplatin (or cisplatin) and paclitaxel IV over 3 hours every 3 weeks for 6 courses. Patients may receive doxorubicin or epirubicin in addition to the standard chemotherapy every 4 weeks. Quality of life is assessed prior to therapy, at 4-6 weeks following completion of therapy, and then at 3 months, 9 months, and 15 months. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 208 patients (104 per treatment arm) will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Sozialmedizinisches Zentrum Ost - Donauspital, Vienna, , Austria

Centre Hospitalier Notre Dame - Reine Fabiola, Charleroi, , Belgium

Charles University, Prague 10, , Czech Republic

Thomayer Memorial Teaching Hospital, Prague 4, , Czech Republic

Staedt Klinikum Karlsruhe GGMBH, Karlsruhe, , Germany

Klinikum Nuernberg - Klinikum Nord, Nuernberg, , Germany

Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi, Bologna, , Italy

Ospedale Santa Chiara, Pisa, , Italy

S. Camillo Hospital, Rome, , Italy

Ospedale San Bortolo, Vicenza, , Italy

National Cancer Institute - Bratislava, Bratislava, , Slovakia

Hospital Universitario San Carlos, Madrid, , Spain

Hospital Clinico Universitario de Valencia, Valencia, , Spain

Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

Cancer Research UK and University College London Cancer Trials Centre, London, England, United Kingdom

Cancer Research Centre at Weston Park Hospital, Manchester, England, United Kingdom

Contact Details

Name: Jonathan A. Ledermann, MD

Affiliation: Cancer Research UK

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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