OXALIPLATIN PLUS 5-FLUOROURACIL BASED-CHEMOTHERAPY INDUCTION FOLLOWED BY PREOPERATIVE CHEMORADIATION VERSUS PREOPERATIVE CHEMORADIATON ALONE IN ADVANCED RECTAL ADENOCARCINOMA: RANDOMIZED CONTROLLED PHASE II STUDY - ADVANCED RECTAL CARCINOMA

Erasme Hospital - Department of Gastroenterology0 个研究点开始时间: 2007年3月2日最近更新: 2013年10月28日

适应症

试验速览

暂无简介。

•Inclusion criteria
•-histologically confirmed rectal adenocarcinoma, located 0-15 cm from the anal margin, T2-4 / N+ amenable to indication for chemoradiotherapy.
•-patients with resectable liver or pulmonary metastases (=3) could be included in this protocol ,providing that chemoradiation is indicated in the treatment plan.
•-age > 18
•-WHO performance status (PS) of 0-2 at study entry
•-measurable (bi-dimensionally with both diameters =1cm) / evaluable disease
•-adequate renal (serum creatinin <1.5x upper reference range), liver (total bilirubin < 1.5x upper reference range) and hematopoietic function (PMN>1,5x 109/L, platelet >100x109/L), PTT = 1,5 upper reference range.
•-life expectancy of at least 12 weeks
•-effective contraception throughout the study for both male and female patients if the risk of conception exist.
•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
•-metastatic disease not amenable to curative surgery (= liver, pulmonary metastases)
•-uncontrolled concurrent CNS, cardiac, infectious diseases
•-previous treatment (chemotherapy or radiotherapy) for this cancer excepted colostomy
•-known hypersensitivity to any components of study treatments
•-previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
•-chronic inflammatory disease of the ileum or the colon
•-Peripheral sensory neuropathy with functional impairment
•-pregnancy or breast feeding
•-medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
•-major surgical procedure ? 28 days prior to randomization
•-Clinically significant cardiovascular disease ( including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ? 12 months prior to randomisation.
•No other restrictions due to age or co-morbid conditions if surgery was not contraindicated.

发起方

Erasme Hospital - Department of Gastroenterology