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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier:
NCT00995202
First received: October 14, 2009
Last updated: August 2, 2016
Last verified: August 2016
  Purpose

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 Intervention Phase
Colorectal Cancer
Other: diagnostic laboratory biomarker analysis
Procedure: computed tomography
Procedure: diagnostic colonoscopy
Procedure: standard follow-up care
Procedure: ultrasound imaging
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study

Resource links provided by NLM:


Further study details as provided by Federation Francophone de Cancerologie Digestive:

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Cost-effectiveness study [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 1997
Study Start Date: September 2009
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Standard Monitoring
In the standard monitoring arm, abdominal ultrasound examination is performed every 3 months for 3 years, then every 6 months for 2 years, then annually. A Chest X-ray is performed every 6 months for 3 years then annually for 2 years.
Other: diagnostic laboratory biomarker analysis Procedure: computed tomography Procedure: diagnostic colonoscopy Procedure: standard follow-up care
Experimental: Intensive monitoring
A thoraco-abdominal-pelvic CT scan alternating with abdominal ultrasound is performed every 3 months for 3 years, then every 6 months for 2 years. CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.
Other: diagnostic laboratory biomarker analysis Procedure: computed tomography Procedure: diagnostic colonoscopy Procedure: ultrasound imaging

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.
  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995202

  Show 117 Study Locations
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Principal Investigator: Come Lepage, Pr Centre Hospitalier Universitaire de Dijon
  More Information

Publications:
Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT00995202     History of Changes
Other Study ID Numbers: CDR0000654114  FFCD-PRODIGE-13  2009-A00536-51  EU-20979 
Study First Received: October 14, 2009
Last Updated: August 2, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 26, 2016