Intensive Versus Minimal Surveillance of Patients With Resected Dukes B2-C Colorectal Carcinoma — GILDA  

Colorectal Cancer Clinical Trial

Official title: A Randomized Trial Of Intensive Versus Minimal Surveillance Of Patients With Resected Dukes B2-C Colorectal Carcinoma

Status Completed

Clinical Trial Summary

Dukes B2-C colorectal cancer patients who had no evidence of disease at the end of their front line treatment (surgery and adjuvant radio-chemotherapy, if indicated) are eligible for the trial and randomized to two different surveillance programs. These programs differ greatly in the frequency of diagnostic imaging. They have similar schedules of physical examinations and carcinoembryonic antigen (CEA) assessments. Patients will receive baseline and yearly health-related quality of life (HR-QoL) questionnaires. Primary outcomes are overall survival and QoL.

Clinical Trial Description

Minimal program for colon cancer: Office visit and CEA at 4,8,12,16,20,24,30,36,42,48, and 60 months. Colonoscopy at 12, and 48 months. Liver echography* at 8, and 20 months.

Intensive program for colon cancer: Office visit, CBC, CEA+CA 19.9 at 4,8,12,16,20,24,30,36,42,48, and 60 months. Colonoscopy at 12, 24, 36, 48,and 60 months. Liver echography* at 4,8,12,16,24,36,48, and 60 months. Chest X-ray at 12,24,36,48,and 60 months.

• Abdominal-pelvis C.T., as an alternative to echography, was a 2° level exam only (doubtful results of physical examination or echography; increasing levels of CEA; predictable poor sensitivity of echography due to obesity or other anatomic-clinical conditions) ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Surveillance

• NCT number: NCT02409472
• Study type: Interventional
• Source: Mario Negri Institute for Pharmacological Research
• Status: Completed
• Phase: N/A
• Start date: April 1998
• Completion date: December 2012