Status:
UNKNOWN
Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced primary resectab...
Detailed Description
Preoperative radiotherapy and 5-FU based chemotherapy, along with the complete resection of the mesorectum is a standard treatment of locally advanced rectal cancer.Capecitabine has the potential to r...
Eligibility Criteria
Inclusion
- Age 18 to 80 if judged fit for surgery
- WHO performance status 0-1
- Histologically proven rectal adenocarcinoma located below the peritoneum
- T3-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI
- No distant metastases
- Adequate haematological, cardiac, liver and renal function
- Signed informed consent
- Appropriate measures for contraception for men and women, if applicable
Exclusion
- Prior radio- and/or chemotherapy
- Others synchronous cancers
- History of other malignant disease
- Significant heart disease
- Known hypersensitivity to biological drugs
- Pregnant or lactating patient
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00689702
Start Date
February 1 2007
End Date
May 1 2013
Last Update
March 26 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Oncology
Ljubljana, Slovenia, Slovenia, 1000