Multicentre international study of capecitabine ± bevacizumab as adjuvant treatment of colorectal cancer. - QUASAR 2
- Conditions
- Histologically proven stage III (stage T2, T3 or T4) and stage II (any one or more of the following – stage T4, lymphatic invasion, vascular invasion, peritoneal involvement, poor differentiation) colon cancer (expected ratio 70%:30%). N.B Patients can be Stage II, T3 as long as they have one of the other poor prognostic features.MedDRA version: 9.1Level: LLTClassification code 10009944Term: Colon cancer
- Registration Number
- EUCTR2004-000629-32-CZ
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1952
1. Histologically proven stage III (stage T2, T3 or T4) and stage II (any one or more of the following – stage T4, lymphatic invasion, vascular invasion, peritoneal involvement, poor differentiation) colon cancer (expected ratio 70%:30%). N.B Patients can be Stage II, T3 as long as they have one of the other poor prognostic features.
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. [If a subject has had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or there is the anticipated need for major surgical procedure during the course of the study they are not eligible].
4. WHO Performance Status 0 or 1.
5. Male or female outpatients age größer/gleich 18 years.
6. Written informed consent given.
7. Life expectancy of größer/gleich 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
1. Previous chemotherapy or immunotherapy.
2. Received any investigational drug or agent/procedure, (i.e. participation in another treatment trial) within 4 weeks of randomisation.
3. Moderate or severe renal impairment [creatinine clearance = 30ml/min (calculated according to Cockroft-Gault formula–see Appendix 4).
4. Any of the following laboratory values (tests must not have been carried out more than 2 weeks prior to randomisation):
a. Absolute neutrophil count (ANC) <1.5 x 109/L
b. Platelet count < 100 x 109/L
c. Total bilirubin > 1.5 ULN
d. ALT, AST > 2.5 x ULN
e. Alkaline phosphatase > 2.5 x ULN
(ULN = Upper Limit of Normal)
5. Patients requiring chronic use of full dose oral or parenteral anticoagulants, high dose aspirin (>325mg/day), anti-platelet drugs or known bleeding diathesis. Low dose aspirin is allowed.
6. Proteinuria > 500 mg/24 hours.
7. Known coagulopathy.
8. Clinically significant cardiovascular disease [i.e. active; or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication; or uncontrolled hypertension].
9. Concomitant treatment with sorivudine or its chemically related analogues such as brivudine.
10. Pregnant (positive pregnancy test within 7 days of starting treatment), 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 the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
14. Chronic inflammatory bowel disease and/or bowel obstruction and/or active peptic ulcer.
15. History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
16. Known dihydropyrimidine dehydrogenase (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; or to any other study drugs.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Disease free survival (3 year);Secondary Objective: - Disease free survival for stage III patients (3 years)<br>- Overall survival (5 year)<br>- Side effect profiles<br>- Translational science<br>;Primary end point(s): Disease-free survival on all patients<br>(Time from randomisation until confirmation of relapse or death from any cause)<br>
- Secondary Outcome Measures
Name Time Method