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

Greater Glasgow Health Board(GGHB)/ University of Glasgow0 个研究点目标入组 652 人开始时间: 2009年9月8日最近更新: 2019年12月10日

试验速览

暂无简介。

•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

•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)

发起方

Greater Glasgow Health Board(GGHB)/ University of Glasgow