Intensive Versus Minimal Surveillance of Patients With Resected Dukes B2-C Colorectal Carcinoma (GILDA)
Primary Purpose
Colorectal Cancer, Surveillance
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surveillance program after completion of primary treatment
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring randomized clinical trial
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
minimal surveillance
intensive surveillance
Arm 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, 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.
Outcomes
Primary Outcome Measures
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause
Health Related Quality of Life
mean scores for Short Form Health Status Survey (SF)12 and Psychological General Well-Being (PGWB) questionnaires
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02409472
First Posted
April 1, 2015
Last Updated
April 8, 2015
Sponsor
Mario Negri Institute for Pharmacological Research
1. Study Identification
Unique Protocol Identification Number
NCT02409472
Brief Title
Intensive Versus Minimal Surveillance of Patients With Resected Dukes B2-C Colorectal Carcinoma
Acronym
GILDA
Official Title
A Randomized Trial Of Intensive Versus Minimal Surveillance Of Patients With Resected Dukes B2-C Colorectal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mario Negri Institute for Pharmacological Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Surveillance
Keywords
randomized clinical trial
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
minimal surveillance
Arm Type
Other
Arm 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.
Arm Title
intensive surveillance
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
surveillance program after completion of primary treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause
Time Frame
5-year OS
Title
Health Related Quality of Life
Description
mean scores for Short Form Health Status Survey (SF)12 and Psychological General Well-Being (PGWB) questionnaires
Time Frame
Yearly assessment over 5 years
Secondary Outcome Measure Information:
Title
Disease free survival (DFS)
Description
DFS is defined as the time from randomization to the earliest occurrence of progression or second primary colorectal cancer in both groups
Time Frame
5-year DFS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Andreoni, MD
Organizational Affiliation
European Institute of Oncology, Milan, Italy
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
26578734
Citation
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.
Results Reference
derived
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Intensive Versus Minimal Surveillance of Patients With Resected Dukes B2-C Colorectal Carcinoma
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