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Gastrointestinal Diseases

Colonic Diseases

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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, complet blood count (CBC), CEA+ Carbohydrate Antigen (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.

These are two different surveillance programs for Dukes B2-C colorectal cancer patients who have no evidence of disease at the end of their front line treatment (surgery and adjuvant radio-chemotherapy, if indicated). These programs differ greatly in the frequency of diagnostic imaging. They had similar schedules of physical examinations and carcinoembryonic antigen (CEA) assessments.

surveillance program after completion of primary treatment

Bruno Andreoni, MD

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.

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)

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

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

OS is defined as the time from randomization to death from any cause

mean scores for Short Form Health Status Survey (SF)12 and Psychological General Well-Being (PGWB) questionnaires

DFS is defined as the time from randomization to the earliest occurrence of progression or second primary colorectal cancer in both groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intensive Versus Minimal Surveillance of Patients With Resected Dukes B2-C Colorectal Carcinoma	NCT02409472	Colorectal Canc... Surveillance	surveillance pr...	18 Years -	Mario Negri Institute for Pharmacological Research
Intensive Versus Minimal Surveillance of Patients With Resected Dukes B2-C Colorectal Carcinoma	NCT02409472	Colorectal Canc... Surveillance	surveillance pr...	18 Years -	Mario Negri Institute for Pharmacological Research

Spots Global Cancer Trial Database for surveillance program after completion of primary treatment