PHASE II STUDY OF NEOADJUVANT CHEMORADIOTHERAPY IN LOCALLY ADVANCED RECTAL CANCER - XELOXART

• Conditions: rectal cancer; MedDRA version: 6.1Level: PTClassification code 10062099

• Registration Number: EUCTR2005-005661-11-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Locally advanced rectal cancer (T3-4 and / or N+)

2) PS 0-1 WHO

3) 18-75 years age

4) written informed consent
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

1) Controindications to surgery

2) Previous oncological therapies

3) Previous malignant tumors (a part skin cancer)

4) Rectal cancer responsible of severe stenosis or significant bleeding

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: efficacy evaluation in terms of pathological complete response to neoadjuvant capecitabine, oxaliplatinum and radiation in locally advanced rectal cancer;Secondary Objective: efficacy evaluation in terms of clinical response to neoadjuvant capecitabine, oxaliplatinum and radiation in locally advanced rectal cancer 2) evaluation of efficacy in terms of sphincter saving surgical procedures in distal rectal cancer 3) Disease free survival evaluation 4)Toxicity evaluation of neoadjuvant treatment 5) Pharmacogenomics and radiogenomics studies;Primary end point(s): pathological complete response to neoadjuvant chemoradiotherapy