Randomized Phase III Trial of Paclitaxel plus Carboplatin (TC) Therapy versus Irinotecan plus Cisplatin (CPT-P) Therapy as a First Line Chemotherapy for Clear Cell Carcinoma of the Ovary

Authors
Category Primary study
JournalUMIN Clinical Trials Registry
Year 2006
INTERVENTION: Paclitaxel 175 mg/m2 day 1+ Carboplatin AUC 6 day 1 q 3 weeks 6 cycles Irinotecan 60 mg/m2 day 1,8,15+ Cisplatin 60 mg/m2 day 1 q 4 weeks 6 cycles CONDITION: clear cell carcinoma of the ovary PRIMARY OUTCOME: Progression ‐ Free Survival SECONDARY OUTCOME: Overall Survival,Response Rate,Adverse Event INCLUSION CRITERIA: 1) Patients with a histological diagnosis of clear cell carcinoma of the ovary, FIGO Stages I to IV. All patients must have had appropriate surgery for ovarian carcinoma with appropriate tissue available for histological evaluation. In the case with concurrent presence of other histological cell types, clear cell histology must be dominant ( > 50%). The histological diagnosis will be confirmed by a central pathology review (CPR) (Three pathology slides required.) 2) Age: 18 or older 3) ECOG Performance Status: 0 ‐ 1 4) Reasonable organ function: Must be assessed within 14 days prior to randomization. Absolute Neutrophil Count: 1,500 / mm3 or more Platelet: 100,000 / mm3 or more Renal Function: Serum creatinine should be 1.5 x institutional ULN or less. If patient has serum creatinine of 1 x ULN to 1.5 x ULN, she must have creatinine clearance > 60 ml/min * Creatinine clearance should be calculated using the Modified Jelliffe formul
Epistemonikos ID: c205d0566bd6a602b25bb064f43308a2956fe919
First added on: Aug 21, 2024