Effektivitätsoptimierte und toxizitätsreduzierte Therapie des metastasierten Kolorektalkarzinoms in der First-line Therapie - ERBIMOX

• Conditions: metastastic colorectal cancer; MedDRA version: 8.1Level: LLTClassification code 10010036Term: Colorectal carcinoma

• Registration Number: EUCTR2006-002744-28-DE
• Lead Sponsor: iOMEDICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-10
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified