Advanced colorectal carcinoma
Conditions
Interventions
Trade Name: Xeloda
Product Name: capecitabine
Pharmaceutical Form: Tablet
Trade Name: Avastin
Product Name: bevacizumab
Product Code: R04876646
Pharmaceutical Form: Concentrate for solution for infus
Sponsors
Dutch Colorectal Cancer Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histological proof of CRC; - Advanced disease not amenable to surgery. No prior systemic treatment for advanced disease; - Distant metastases; - Unidimensionally measurable disease; - In case of previous radiotherapy, at least one measurable lesion located outside irradiated field - Prior adjuvant treatment for stage II/III colorectal cancer is allowed if last chemotherapy was given > 6 months before the start of induction treatment; - Age 18 years and above; - CT scan thorax and abdomen performed = 4 weeks prior to the start of induction treatment; - Negative pregnancy test in women with childbearing potential. - At least stable disease at the end of the induction phase. 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
Exclusion criteria: - CNS metastases; - History of a second malignancy = 5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin; - Previous intolerance of capecitabine, oxaliplatin, and/or bevacizumab for which any of these drugs have been permanently discontinued; - Known dihydropyrimidine dehydrogenase (DPD) deficiency; - (Planned) radical resection of all metastatic disease; - Uncontrolled hypertension; - Use of >3 antihypertensive drugs; - Significant cardiovascular disease < 1 yr before randomisation; - Chronic active infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate and assess: · Progression-free survival after either observation vs. maintenance therapy (PFS1) · Response rate during re-introduction of MTD chemotherapy and bevacizumab · Overall survival · Quality of life · Toxicity · Translational research on biological factors that may predict response to treatment.;Primary end point(s): Progression-free survival (PFS2) after re-introduction of MTD chemotherapy.;Main Objective: To assess the progression-free survival (PFS2) after re-introduction of MTD chemotherapy after observation (arm A) versus maintenance treatment with low-dose capecitabine plus bevacizumab (arm B) in patients with advanced colorectal cancer with stable disease or better after induction treatment with capecitabine, oxaliplatin, and bevacizumab. | — |
Countries
Netherlands
Outcome results
None listed