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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
Mario Negri Institute for Pharmacological Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring randomized clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 1, 2015
    Last Updated
    April 8, 2015
    Sponsor
    Mario Negri Institute for Pharmacological Research
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    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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