Carboplatin and Paclitaxel (Taxol) versus Carboplatin and Paclitaxel (Taxol) followed by Carboplatin for frontline chemotherapy in advanced ovarian carcinoma. A Hellenic Cooperative Oncology Group Study
Carboplatin and Paclitaxel (Taxol) (8 cycles) versus Carboplatin and Paclitaxel (Taxol) (4 cycles) followed by Carboplatin (4 cycles) for frontline chemotherapy in advanced ovarian carcinoma. A randomised phase III study of overall survival by the Hellenic Cooperative Oncology Group
Hellenic Cooperative Oncology Group
412 participants
Apr 4, 2005
Interventional
Conditions
Summary
This is a randomized trial comparing carboplatin and paclitaxel (8 cycles) versus carboplatin and paclitaxel (4 cycles) followed by carboplatin (4 cycles) for frontline chemotherapy in advanced ovarian carcinoma. The main objective is to evaluate overall survival and. secondary endpoints are to evaluate disease-free survival, best response rate and to compare toxicity (especially neuroroxicity), between the two treatment arms.
Eligibility
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Interventions
PACLITAXEL (TAXOL): 175mg/m2 intravenous (i.v.) over 3 hours (h) only on day 1 of each cycle, cycles 1 to 4 CARBOPLATIN: Area under the curve (AUC)6 i.v. over 1h only on day 1 of each cycle, cycles 1 to 4 Followed by CARBOPLATIN: 6 AUC i.v. over 1h only on day 1 of each cycle, cycles 5 to 8 Duration of therapy: 1 day per cycle. Cycles are repeated every 21 days.
Locations(1)
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ACTRN12610000309088