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Cetuximab with Neoadjuvant Chemoradiation for Rectal Cancer
NCT00611858Phase 2
Key facts
- Status
- Terminated
- Start
- May 2008
- Primary completion
- Dec 2012
- Countries
- 1
- Sponsor
- Dana-Farber Cancer Institute
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- cetuximab
- Conditions
- rectal cancer
01
Overview
Phase 2, open-label, single-arm trial of cetuximab in rectal cancer, sponsored by Dana-Farber Cancer Institute. Primary endpoint: Pathological Complete Response Rate at 24 weeks. Started May 2008; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Cetuximab, 5-FU and Radiation
Cetuximab lead-in followed by Cetuximab + 5-FU + Radiation
03
Who it enrols
Patients with histologically confirmed locally advanced (T3/T4 or node positive) rectal adenocarcinoma, KRAS wildtype, no distant metastases, and no prior pelvic radiation or EGFR/5-FU therapy.
04
Endpoints
Primary
Pathological Complete Response Rate
Secondary
Local Recurrence Rate
Complete Resection Rate
Distant Recurrence Rate
Incidence of Grade 4 Treatment-Related Toxicity
1-Year Overall Survival Rate
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