Multicentre international study of capecitabine ± bevacizumab as adjuvant treatment of colorectal cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2240

Inclusion Criteria

1. Histologically proven stage III and stage II colorectal cancer.
2. Patients must have undergone complete resection of the primary tumour without evidence of residual disease.
3. Patients must be randomised to start treatment a minimum of 28 days and maximum of 70 days after surgery.
4. WHO performance status 0 or 1.
5. Male or female patients age >= 18 years.
6. Written informed consent given.
7. Life expectancy of >= 5 years, in terms of non-cancer-related morbidity.

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

1. Previus chemotherapy, immunotherapy or infra-diaphragmatic radiotherapy or patients who are expected to require radiotherapy to these sites within the next 12 months, for any reason.
2. Received any investigational drug or agent/procedure within 4 weeks of randomisation.
3. Moderate or severe renal impairment.
4. Any of the following laboratory values:
ANC < 1.5 x 10Exp9/L
platelet count < 100 x 10Exp9/L
total bilirubin > 1.5 ULN
ALT, AST > 2.5 x ULN
alkaline phosphatase > 2.5 x ULN
5. Patients requiring chronic use of full dose oral or parenteral anticoagulants, high dose aspirin (> 325 mg/day), anti-platelet drugs or known bleeding diathesis. Low dose aspirin allowed.
6. Proteinuria > 500 mg/24 hours.
7. Known coagulopathy.
8. Clinically significant cardiovascular disease.
9. Concominant treatment with sorivudine or its chemically related analogues.
10. Pregnant or lactating women.
11. Sexually active patients of child bearing potential not using adequate contraception (male and female).
12. Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease free interval of at least 10 years.
13. Lack of physical integrity of upper GI tract, malabsorption syndrome or inability to take oral medication.
14. Chronic inflammatory bowel disease and/or active peptic ulcer, either of which have been active or required medication in the last 2 years.
15. History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the investigator to be clinically significant.
16. Known DPD deficiency.
17. Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main study objective is to compare the efficiacy of the two regimens: standard chemotherapy with capecitabine against capecitabine + bevacizumab. Primary endpoint is disease free survival. Secondary endpoints: disease free survival for stage III patients, overall survival, safety profiles.;Secondary Objective: ;Primary end point(s): Disease free survival

Secondary Outcome Measures

Name	Time	Method

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