behandling af patienter med avanceret rectumcancer med capecitabin og oxaliplatin før under og efter kurativt intenderet strålebehandling, samt tillæg af cetuximab til patienter der er K-RAS vild-type
Phase 1
- Conditions
- we will give capecitabine and oxaliplatin togehter with radiation to patient with rectum cancer T3 and T4. We will add cetuximab to patients who are K-RAS wild-typeMedDRA version: 9.1Level: LLTClassification code 10002124Term: Anal canal cancer
- Registration Number
- EUCTR2009-010976-94-DK
- Lead Sponsor
- herlev hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Non-resectable rectum cancer T3 and T4, PS 0-1
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
Expected lifetime less than 3 month
No concurrent disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: evaluate response to the treatment;Secondary Objective: safety;Primary end point(s): response rate
- Secondary Outcome Measures
Name Time Method