Cetuximab (Erbitux®), capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer: A phase II Pilot Study
- Conditions
- ocally advanced, resectable stage II/III rectal cancer.
- Registration Number
- EUCTR2006-001371-38-SI
- Lead Sponsor
- Institute of Oncology Ljubljana
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Age 18 to 80 if judged fit for surgery.
- WHO peformance 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 infomed consent.
- Appropriate measures for contraception for men and women, if applicable.
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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The pathological complete response rate.;Secondary Objective: - The rate of sphincter sparing surgical procedure (according to estimated APR before neoadjuvant treatment).<br>- Toxicity and safety.;Primary end point(s): Pathological complete response rate.
- Secondary Outcome Measures
Name Time Method