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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Surveillance
• Intervention / Treatment: Other: surveillance program after completion of primary treatment

Detailed 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 Type: Interventional
• Enrollment (Actual): 1242
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with histologically proven adenocarcinoma of the colon or rectum with Dukes Astler-Coller modification stage B2-C who had been treated with curative intent (radical excision ± adjuvant radio-chemotherapy) .
• Eligible patients had to be free of known cancer prior to study entry as attested by negative results of endoscopy, liver ultrasonography, chest roentgenography and serum CEA level performed < 4 months before randomization

Exclusion Criteria:

• Inability to undergo testing (disability, allergy to contrast agents, etc.) and patients geographically not amenable to full follow-up.
• Patients enrolled onto any other research protocol that requires strict adherence to any specific follow-up practice.
• A history of any previous malignancy in the last 10 years (other than carcinoma in situ of the cervix or non-melanoma skin cancer).
• No informed consent to participate in the trial according to local regulatory guidelines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: minimal surveillance; 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.	Other: surveillance program after completion of primary treatment; 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.
Other: intensive surveillance; 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.	Other: surveillance program after completion of primary treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to death from any cause	5-year OS
Health Related Quality of Life	mean scores for Short Form Health Status Survey (SF)12 and Psychological General Well-Being (PGWB) questionnaires	Yearly assessment over 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival (DFS)	DFS is defined as the time from randomization to the earliest occurrence of progression or second primary colorectal cancer in both groups	5-year DFS

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Investigators: Study Chair: Bruno Andreoni, MD, European Institute of Oncology, Milan, Italy

Publications and helpful links

General Publications

• Rosati G, Ambrosini G, Barni S, Andreoni B, Corradini G, Luchena G, Daniele B, Gaion F, Oliverio G, Duro M, Martignoni G, Pinna N, Sozzi P, Pancera G, Solina G, Pavia G, Pignata S, Johnson F, Labianca R, Apolone G, Zaniboni A, Monteforte M, Negri E, Torri V, Mosconi P, Fossati R; GILDA working group. A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma. Ann Oncol. 2016 Feb;27(2):274-80. doi: 10.1093/annonc/mdv541. Epub 2015 Nov 16.

Study record dates

Study Major Dates

• Study Start: April 1, 1998
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 3, 2015
• First Posted (Estimate): April 6, 2015

Study Record Updates

• Last Update Posted (Estimate): April 9, 2015
• Last Update Submitted That Met QC Criteria: April 8, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: randomized clinical trial
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: GILDA