Randomized phase III study of neoadjuvant chemotherapy followed by surgery vs. concomitant radiotherapy and chemotherapy in FIGO Ib2, IIa > 4 cm or IIb cervical cancer.

European Organisation for Research and Treatment of Cancer0 个研究点目标入组 686 人开始时间: 2009年9月1日最近更新: 2020年7月13日

适应症

试验速览

暂无简介。

•- Cervical carcinoma of following histological types: squamous cell carcinoma, adenosquamous cell or adenocarcinoma
•- FIGO stage Ib2, IIa >4cm or IIb
•- WHO performance status of 0-2
•- 18 - 75 years
•- No prior irradiation or chemotherapy
•- No previous or concurrent second malignanct except for adequately treated basal cell carcinoma of the skin
•- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient)
•- not pregnant
•- ANC > 1.5 x 109/l, platelets > 100 x 109/l, bilirubin < 25 µmol/l or < 1.46 mg/dl, creatinine clearance (calculated or measured) > 60 ml/min
•- Before patient randomization, written informed consent must be given according to ICH/GCP and national/local regulations.
•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 528
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 51

•- Small cell, clear cell and other rare variants of the classical adenocarcinoma
•- prior irradiation or chemotherapy
•- previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin
•- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient before registration in the trial)
•- pregnant

发起方

European Organisation for Research and Treatment of Cancer