Maintenance treatment with capecitabine and bevacizumab versus observation after induction treatment with capecitabine, oxaliplatin, and bevacizumab as first-line treatment in patients with advanced colorectal carcinoma, a randomised phase III study (CAIRO3 study) - CAIRO3
- Conditions
- Advanced colorectal carcinoma
- Registration Number
- EUCTR2006-006657-27-NL
- Lead Sponsor
- Dutch Colorectal Cancer Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To evaluate and assess:<br>·Progression-free survival after either observation vs. maintenance therapy (PFS1)<br>·Response rate during re-introduction of MTD chemotherapy and bevacizumab<br>·Overall survival<br>·Quality of life<br>·Toxicity <br>·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.
- Secondary Outcome Measures
Name Time Method