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

Phase 1

• Conditions: Clear Cell Carcinoma of the Ovary; MedDRA version: 9.1 Level: LLT Classification code 10033131 Term: Ovarian carcinoma

• Registration Number: EUCTR2007-007849-13-GB
• Lead Sponsor: Greater Glasgow Health Board(GGHB)/ University of Glasgow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-08
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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%). For UK patients 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 other malignancies including 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)
Pregnant and lactating women should be excluded
Patients with known hypersensitivity to polyoxythylated castpr oil or any of four chemotherapeutic agents (Paclitaxel, Carboplatin, Irinotecan and Cisplatin)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified