This trial is active, not recruiting.

Condition rectal cancer
Treatment cetuximab, capecitabine
Phase phase 2
Sponsor Institute of Oncology Ljubljana
Start date February 2007
End date April 2009
Trial size 43 participants
Trial identifier NCT00689702, EMR 62202-688


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 resectable rectal cancers.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Complete pathological remission rate
time frame: at pathological examm of surgical speciment

Secondary Outcomes

Rate of sphincter sparing surgical procedure Toxicity/safety
time frame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study
Principal investigator Vaneja Velenik, PhD, MD
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 replace 5-FU as standard agent. Cetuximab is a monoclonal antibody directed against EGFR. Both agents are active in treatment of colorectal cancer and have demonstrated radiosensitising properties.The trial aims to assess the efficacy, safety and toxicity of the combination of cetuximab, capecitabine and radiation in patients with stage II and III rectal cancer.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Institute of Oncology Ljubljana.