Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer (XERT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study|
- Complete pathological remission rate [ Time Frame: at pathological examm of surgical speciment ] [ Designated as safety issue: No ]
- Rate of sphincter sparing surgical procedure Toxicity/safety [ Time Frame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2007|
|Estimated Study Completion Date:||May 2013|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Drug: cetuximab, capecitabine
Cetuximab 400mg/m2 in iv infusion as an initial dose on day 15, then a weekly dose of 250mg/m2 for 5 weeks during radiotherapy (days 22, 29, 36, 43, 50).
Capecitabine: 1250 mg/m² bd for 14 days (1 cycle); 825mg/m2 bd over 5 weeks during radiotherapy.
Radiotherapy: planned total dose of 45 Gy in 25 fractions using a four-field plan in 5 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689702
|Institute of Oncology|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Vaneja Velenik, PhD, MD||Institute of Oncology, Ljubljana, Slovenia|