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

UMIN ID: UMIN000000499

Registered date:10/10/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: clear cell carcinoma of the ovary
• Date of first enrollment: 2006/10/01
• Target sample size: 662
• Countries of recruitment: Japan,Asia(except Japan),Europe
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Progression - Free Survival
• Secondary Outcome: Overall Survival,Response Rate,Adverse Event

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1) Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential 2) Patients with other malignancies including synchronous primary endometrial cancer or a past history of primary endometrial cancer 3) Patients who have received prior chemotherapy or radiation therapy to treat the current disease 4) Patients who received intraperitoneal chemotherapy at the time of operation 5) Patients with a prior diagnosis of malignancy are not eligible. Exceptions are: - stage 0 endometrial cancer - carcinoma in situ of the cervix - non-melanoma skin cancer - other malignancies curatively treated and > 5 years without evidence of recurrence 6) Patients who have received prior radiotherapy Exceptions Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease. 7) Patients who have received prior chemotherapy. Exceptions Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 5 years prior to registration, and that the patient remains free of recurrent or metastatic disease. 8,9,10) Patients with diarrhea greater than CTCAE grade1, active infection that requires antibiotics, ongoing gastrointestinal bleeding requiring blood product support 11) Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients with evidence of abnormal cardiac conduction are eligible if their disease has been stable for the past six months. 12,13,14,16) Patients with bowel obstruction, interstitial pneumonitis, massive pleural effusion and/or ascites, known hypersensitivity to polyoxyethylated castor oil or any of four chemotherapeutic agents 15,17,18) Patients who are under treatment with Atazanavir, pregnant or lactating, would not permit completion of study or required follow-up.

Related Information

• Primary Sponsor: Japanese Gynecologic Oncology Group
• Source(s) of Monetary Support: Japanese Gynecologic Oncology Group