Colorectal Cancer Clinical Trial
— GILDAOfficial title:
A Randomized Trial Of Intensive Versus Minimal Surveillance Of Patients With Resected Dukes B2-C Colorectal Carcinoma
Verified date | April 2015 |
Source | Mario Negri Institute for Pharmacological Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1242 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mario Negri Institute for Pharmacological Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | OS is defined as the time from randomization to death from any cause | 5-year OS | No |
Primary | 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 | No |
Secondary | 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 | No |
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