A Randomised Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Proapectively the Prognostic Value of Molecular Markers
- Conditions
- Stage II colon cancer.MedDRA version: 9.1Level: PTClassification code 10009954Term: Colon cancer stage II
- Registration Number
- EUCTR2007-001195-36-IE
- Lead Sponsor
- All Ireland Cooperative Oncology Research Group (ICORG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3610
The distal extent of the tumour must be >/= 12cm from the anal verge.
Patients must have a paraffin-embedded tumour specimen available for the evaluation of risk that is less than 50 days old.
A histologically confirmed adenocarcinoma of the colon that meets Stage II carcimona criteria.
>/= 8 lymph nodes must have been evaluated and reported.
Patients with prior malignancies, including colorectal cancers, are eligible if they have been disease free for >/= 5 years and are deemed by their physician to be at low risk of recurrence. Patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomisation.
Patients must be >/= 18 years old.
Patients must have ECOG performance status of 0-2.
Patient must, within 2 weeks prior to randomisation, have:
- postoperative absolute granulocyte count of >/=1500/mm3 (or <1500/mm3, if in the opinion of the investigator, this represents an ethnic or racial variation of normal)
- postoperative platelet count of >/= 100,000/mm3
- postoperative evidence of adequate hepatic function
- postoperative evidence of adequate renal function
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
A history of isolated, distant, non-contiguous intra-abdominal metastices, even if restricted.
A presence of complete obstruction or perforation of the bowel.
Systemic or radiation therapy initiated for this malignancy.
Any significant bleeding that is not related to the primary colon tumour within 6 months prior to study entry.
Gastroduodenal ulcer(s) determined to be active by endoscopy.
Patients with a history od hypertension must have a measurement of <150/90 and be on a stable regimen of anti-hypertensive therapy.
A serious or non-healing wound, skin ulcers or bone fractures.
Concomitant halogenated antiviral agents.
Clinically significant peripheral neuropathy at the time of step 2 randomisation.
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomisation.
Core biopsy or other minor procedure, excluding placement of a vascular access device, within 7 days prior to randomisation.
Anticipation of a need for major surgical procudure(s) during the course of the study.
Patients must begin adjuvant treatment no less than 28 days and no more than 60 days from surgery.
Eligible patients of reproductive potential (both sexes) must agree to use an accepted and effective method of contraceptive during study therapy and for at least 3 months after the completion of bevacizumab.
Women must not be pregnant or breast-feeding at study entry.
Patients with PT (INR) >1.5 are not eligible, unless the patient is on full-dose anticoagulants.
Patients with non-malignant systemoc disease (cardiovascular, renal, hepatic etc) that would preclude any of the study therapy drugs are elegible. Specifically excluded are patients with NYHA Class III or IV cardiac disease or current symptomatic arrhythmia.
A hisotory of Transient Ischemic Attack (TIA) or cerebrovascular accident (CVA).
A history of the following within the 12 months of study entry:
- arterial thromboembolic events
- unstable angina
- Myocardial Infarction
Symptomatic Peripherial Vascular Disease
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method