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
- Conditions
- advanced rectal adenocarcinomaMedDRA version: 9.1Level: LLTClassification code 10038028Term: Rectal adenocarcinoma stage III
- Registration Number
- EUCTR2006-006646-34-BE
- Lead Sponsor
- Erasme Hospital - Department of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess if chemotherapy before chemoradiation can increase tumor downstaging in rectal cancer;Secondary Objective: Toxicity <br>Disease free survival;Primary end point(s): The primary objective of the study is to compare the achievement of a pT0-1 stage in each arm . The pT0-1 stage will be assessed as a binary variable.<br>Assuming a rate of 20% pT0-1 stage in the radiochemotherapy arm, we calculated that we would need a sample of 110 patients (55 in each arm) to ensure 80% statistical power of detecting an improvement of 25% pT0-1 stage with a two-sided significance level of 0.05.<br>Secondary end-points are tumoral and nodal down staging, sphincter preservation.<br>
- Secondary Outcome Measures
Name Time Method