Radio-controlled Surgery RGS in the cancer of the rectum clinical study of feasibility to improve the treatment and prognosis - ND

• Conditions: carcinoma of the rectum; MedDRA version: 8.1Level: PTClassification code 10038038Term: Rectal cancer

• Registration Number: EUCTR2006-001499-18-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Histologic diagnosis of carcinoma of rectum PS 70 according to Karnovsky Age 18 years
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

Patient not electable; Women in pregnancy and breast-feeding

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the effectiveness, the accuracy and sensibility of the technology of the radioisotope in the finding of LS in the cancer of the rectum or its relapses;Secondary Objective: Comparison between appraisal RGS and the preoperative instrumental stage; Comparison between appraisal RGS and the histopathological characterization;;Primary end point(s): Validation of methodology in the cancer of the rectum.