metastastic colorectal cancer MedDRA version: 8.1 Level: LLT Classification code 10010036 Term: Colorectal carcinoma
Conditions
Interventions
Trade Name: Erbitux 5 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923564
Current Sponsor code: EMD271786
Other descriptive name: Cetuximab
Concentrat
Sponsors
iOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - histologically verified colorectal carcinoma with KRAS wildtyp status - no previous chemotherapy of the metastasised colorectal carcinoma (first-line therapy) - at least 1 measurable lesion according to RECIST-criteria - adequate function of liver, kidney and hematopoiesis - written informed consent 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: - mutated KRAS expressing colorectal carcinoma - contra-indication against Fluorouracil, Oxaliplatin or Cetuximab - adjuvant therapy with Oxaliplatin up to one year prior to study start - severe neuropathy (CTC-level >2) caused by adjuvant therapy with Oxaliplatin - existant other malignant diseases within the last 5 year (except for: condition after surgery of carcinoma in situ of the uterus or of a basilioma) - existant polyneuropathy - therapeutic radiation or operation within 2 weeky prior to study start - participation in other clinical trials within 4 weeks prior to study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify the superiority of a combined chemo-immuno-therapy compared to exclusive chemotherapy.;Secondary Objective: - duration of remission CR / PR - duration of progression-free survival (PFS) - percentage of patients without progression after 4, 6, 9 and 12 month - survival time (overall survival = OS) - resection rate - safety proifile;Primary end point(s): progression of tumor (new lesions or increase by more than 20% acc to RECIST criteria) | — |
Countries
Germany
Outcome results
None listed