Avastin and chemotherapy followed by a KRAS stratified randomization to maintenance treatment for first line treatment of metastatic colorectal cancer - ACT2
- Conditions
- Patients with previously untreated metastatic colorectal carcinoma.MedDRA version: 14.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-019815-40-DK
- Lead Sponsor
- Skåne University Hospital, Department of Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 230
1. Untreated metastatic colorectal carcinoma.
2. Age 18 years or more.
3. Measurable disease according to Response Evaluation Criteria in Solid Tumors
(RECIST) criteria.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
5. Life expectancy more than 3 months.
6. Adequate haematological, renal and liver function.
7. Tumor tissue available for determination of KRAS mutational status.
8. Blood sample and paraffin embedded tumor tissue for translational research.
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. Adjuvant therapy within 6 months.
2. Central nervous system (CNS) metastases.
3. Clinically significant atherosclerotic vascular disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method