Intensive Versus Minimal Surveillance of Patients With Resected Dukes B2-C Colorectal Carcinoma (GILDA)
April 8, 2015 updated by: Mario Negri Institute for Pharmacological Research
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
Intervention / 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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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.
|
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)
Time Frame: 5-year OS
|
OS is defined as the time from randomization to death from any cause
|
5-year OS
|
|
Health Related Quality of Life
Time Frame: Yearly assessment over 5 years
|
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)
Time Frame: 5-year 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
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Bruno Andreoni, MD, European Institute of Oncology, Milan, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- GILDA
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