Liver metastatis of colorectal cancer.
Conditions
Interventions
Sponsors
the Dutch Colorectal Cancer Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent obtained prior to any study-specific procedure. 2. Age = 18 years. 3. Liver metastases radically resected (R0 resection) 4. Study medication started =4 and = 8 weeks post liver surgery. 5. Histologically confirmed liver metastasis of colorectal cancer after surgery. 6. ECOG performance status 0 or 1 (Appendix 1). 7. Adequate hematology: neutrophils =1.5 x 109/L, platelets =100 x 109/L, Hb =5.5 mmol/L, INR = 1.5, APTT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Extrahepatic metastatic disease. 2 Adjuvant chemotherapy given grade 1. Absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible. 14 Organ allografts requiring immunosuppressive therapy. 15 Serious, non-healing wound, ulcer, or bone fracture. 16 Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. 17 Chronic, daily treatment with high-dose asprin (>325 mg/day) or nonsteroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases). Patients can be rendered eligible by changing the treatment to COX II inhibitors. 18 Chronic treatment with corticosteroids (dose of =10 mg/day methylprednisolone equivalent excluding inhaled steroids). 19 Serious intercurrent infections (uncontrolled or requiring treatment). 20 Current or recent (within the 28 days prior to randomisation) treatment with another investigational drug or participation in another investigational study. 21 Patients with known allergy to Chinese hamster Ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation, platinum compounds or to any other component of the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The main endpoint of this study is Disease Free Survival, DFS. From our own series of patients it could be estimated that the 3-year DFS of patients treated without chemotherapy is 25%. In the control arm, XELOX alone could increase the 3 year DFS to 35%. It is expected that the arm with XELOX plus bevacizumab should result in an improvement of further 10%, bringing the 3 year DFS to 45%. This corresponds to a hazard rate ratio of 0.761 for the bevacizumab arm. A total of 620 patients will be randomized to this study (310 in each arm). With a yearly accrual rate of 150 patients, this number of patients could be accrued in approximately 4 years. If patients are followed for 2 years further, a total amount of 420 events (recurrences or deaths) would be observed. This number of events will provide 80% power to detect the above stated difference in the DFS curves in both arms. The total duration of the study will be 6 years (4 years accrual and 2 further years follow up). (statistics performed by O. Dalesio, Netherlands Cancer Institute) ;Main Objective: The primary objective of this trial is to demonstrate that adjuvant treatment with the combination of bevaxizumab and XELOX is superior to XELOX alone as adjuvant chemotherapy in terms of disease free survival.;Secondary Objective: The secondary objectives of this trial is to demonstrate that adjuvant treatment with the combination of bevacizumab and XELOX is superior to XELOX alone as adjuvant treatment in terms of overall survival. Safety and quality of life. | — |
Countries
Sweden
Outcome results
None listed