XERXES: Examining the role of early neoadjuvant and synchronous Erbitux in pre-operative chemo-radiotherapy using Xeloda followed by excisional surgery. A phase I/II dose escalation study of intravenous erbitux (cetuximab) in combination with 5 day weekly oral Xeloda (capecitabine) and preoperative radiotherapy in rectal cancer. - XERXES

Phase 1

• Conditions: ocally advanced rectal cancer

• Registration Number: EUCTR2004-001926-26-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-02
• Study Completion: 2015-11-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

Biopsy proven adenocarcinoma of the rectum (tumour <15cm from anal verge); Indication for pre-operative chemoradiotherapy by virtue of partially fixed/unresectable disease and locally advanced disease (T3/T4) where the preoperative MRI confirms the surgeon is unlikely to perform a R0 resection; WHO performance status 0 or 1; Age =18 and fit for surgery.
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

Exclusion Criteria

Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude trial therapy or informed consent; Previous radiotherapy to the pelvis; Previous chemotherapy or radiation for rectal cancer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and toxicity of the combination of erbitux, capecitabine and radiotherapy. This will be determined through an assessment of the patient’s toxicity;Secondary Objective: To determine the efficacy of the treatment schedules. This will be determined through an evaluation of disease-free survival.;Primary end point(s): Acute Toxicity (grade 3 or above in defined Dose Limiting Toxicities)