CLINICAL TRIAL COMPARING STANDARD CHEMORADIOTHERAPY VERSUS RADIOTHERAPY ALONE WITH DOSE INTENSIFICATION IN THE PREOPERATIVE APPROACH OF RECTAL CANCER

• Conditions: Patients with operable rectal cancer; MedDRA version: 14.1Level: PTClassification code 10062099Term: Rectal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005638-20-IT
• Lead Sponsor: CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

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

Inclusion Criteria

Eligibility criteria include histopathologically confirmed rectal adenocarcinoma with an
inferior border within 15 cm of the anal verge. The tumor has to have evidence of T3 or T4
disease on MRI or endoluminal ultrasound. Patients with unresectable mestastatic disease,
with an ECOG performance status > 3 and patients not deemed fit for radiotherapy,
capecitabine or surgery are excluded. Pregnant or lactating patients, women with child
bearing potential who lack effective contraception and patients below 18 years old are
excluded as well
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

- ECOG Performance status >3
- previous pelvic radiation therapy and/or chemotherapy
- patients with inoperable rectal cancer
- unresectable distant metastases

Study & Design

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