Randomised 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 - CCC-1

Conditions: Clear Cell Carcinoma of the Ovary
MedDRA version: 9.1Level: LLTClassification code 10033131Term: Ovarian carcinoma

Registration Number: EUCTR2007-007849-13-FR

Lead Sponsor: Kitasato institute clinical trial coordinating center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 652

Inclusion Criteria

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 cases with concurrent presence of other histological cell types, clear cell histology must be dominant (>50%). Histology will be confirmed by central pathology review prior to registration.
Age: 18 or older
ECOG performance status 0-1
Reasonable organ function
Patient must have signed informed consent
Patients must be enrolled within 6 weeks after comprehensive staging surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with a current diagnosis of epithelial ovarian tumour of low malignant potential (borderline carcinomas)
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer
Prior chemotherapy or radiation therapy to treat the current disease
Patients who received intraperitoneal chemotherapy at the time of operation
Prior diagnosis of malignancy (other than non-melanoma skin cancer or other malignancies curatively treated and > 5 years without evidence of recurrence)
Patients who have received prior radiotherapy (exceptions are: 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 that the patient remains free of recurrent or metastatic disease)
Patients who have received prior chemotherapy (exceptions are: 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare effectiveness and safety of the two chemotherapy regimens in patients with stages I,II,III and IV clear cell carcinoma of the ovary;Secondary Objective: ;Primary end point(s): Progression Free Survival<br>Overall survival<br>Response Rate<br>Adverse Events (Frequency and grade)

Secondary Outcome Measures