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Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer (SURVEILLANCE)

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ClinicalTrials.gov Identifier: NCT00995202
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Study Description
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Brief Summary:

RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Standard Monitoring CEA Procedure: Intensive Monitoring CEA Procedure: Standard Monitoring Imagery Procedure: Intensive Monitoring Imagery Phase 3

Detailed Description:

OBJECTIVES:

  • Evaluate the efficacy of reinforced versus standard follow-up care and the utility of follow-up CEA assessments in patients with fully resected stage II or III colorectal cancer.

OUTLINE: This is a multinational/multicenter study. Patients are randomized to 1 of 2 follow-up arms.

  • Standard follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo abdominal ultrasound every 3 months until year 3 and then every 6 months until year 5; chest x-ray every 6 months until year 3 and then annually until year 5; and colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.
  • Reinforced follow-up: Patients undergo clinical assessments every 3 months until year 3 and every 6 months until year 5. They are then assessed at least yearly thereafter. Patients undergo alternate assessments every 3 months comprising thoraco-abdomino-pelvic CT scan or abdominal ultrasound until year 3 and then every 6 months until year 5. They also undergo colonoscopy at 3 years after surgery then every 3 to 6 years thereafter.

Patients undergo a second randomization to 1 of 2 follow-up arms at the beginning of the study.

  • CEA measurement: Patients undergo measurement of CEA levels every 3 months until year 3, every 6 months until year 5, and at least yearly thereafter.
  • No CEA measurement: Patients do not undergo CEA measurement. Blood and tissue blocks of normal and tumor tissues are collected for the validation of protein serum, genetics, or immunologic markers predictive for relapse.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1997 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This study is a surveillance study not an interventional study with products
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
Actual Study Start Date : September 2009
Actual Primary Completion Date : December 2019
Actual Study Completion Date : June 2021
Arms and Interventions
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Arm Intervention/treatment
Standard Monitoring CEA/ Standard Imagery
No specific follow-up of CEA and Standard imagery
 Procedure: Standard Monitoring CEA
No specific follow-up of CEA

Procedure: Standard Monitoring Imagery
Abdominal ultrasound examination every 3 months during 3 years then every 6 months during 2 years then annually. Chest X-ray examination eveyr 6 months during 3 years then annually during 2 years
Intensive monitoring CEA/ Standard Imagery
Intensive follow-up CEA and Standard imagery .
 Procedure: Intensive Monitoring CEA
CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.

Procedure: Standard Monitoring Imagery
Abdominal ultrasound examination every 3 months during 3 years then every 6 months during 2 years then annually. Chest X-ray examination eveyr 6 months during 3 years then annually during 2 years
Intensive Monitoring CEA / Intensive Monitoring Imagery
Intensive follow-up CEA and Intensive imagery
 Procedure: Intensive Monitoring CEA
CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.

Procedure: Intensive Monitoring Imagery
Alternation every 3 months of TDM thoraco-abdomino-pelvis and abdominal ultrasound examination during 3 years and twice a year after during 2 years. Coloscopy at 3 years and then evry 5 years if normal
Standard Monitoring CEA/ Intensive Monitoring Imagery
No specific follow-up of CEA and Intensive Imagery
 Procedure: Standard Monitoring CEA
No specific follow-up of CEA

Procedure: Intensive Monitoring Imagery
Alternation every 3 months of TDM thoraco-abdomino-pelvis and abdominal ultrasound examination during 3 years and twice a year after during 2 years. Coloscopy at 3 years and then evry 5 years if normal


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: 5 years ]
    Time between randomization and date of death (all causes)


Secondary Outcome Measures :
  1. Disease-free survival rate [ Time Frame: 5 years ]
    Time between randomization and first recurrence (local or metastatic) or death (all causes)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically confirmed adenocarcinoma of the colon or rectum

    • Stage II or III disease
    • No distant metastatic disease
  • Has undergone curative resection for no residual tumor
  • Carcinoembryonic antigen (CEA) ≤ 1.5 x upper limit of normal after surgery

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No inflammatory bowel disease
  • No other malignancy within the past 5 years except basal cell carcinoma of the skin and/or carcinoma in situ of the cervix
  • No genetic syndromes

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995202


Locations
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Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
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Principal Investigator: Come Lepage, Pr Centre Hospitalier Universitaire Dijon
More Information
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Publications:

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Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT00995202    
Other Study ID Numbers: PRODIGE 13
FFCD-PRODIGE-13
2009-A00536-51
EU-20979
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Keywords provided by Federation Francophone de Cancerologie Digestive:
stage II colon cancer
stage II rectal cancer
stage III colon cancer
 stage III rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases