XERT: Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer

Sponsor

Institute of Oncology Ljubljana (Other)

Overall Status

Unknown status

CT.gov ID

NCT00689702

Collaborator

(none)

Enrollment

Location

74.9

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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 resectable rectal cancers.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Drug: cetuximab, capecitabine	Phase 2

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Apr 1, 2009

Anticipated Study Completion Date :

May 1, 2013

Outcome Measures

Primary Outcome Measures

Complete pathological remission rate [at pathological examm of surgical speciment]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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