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

Federation Francophone de Cancerologie Digestive

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Procedure: Standard Monitoring CEA; Procedure: Standard Monitoring Imagery; Procedure: Intensive Monitoring Imagery; Procedure: Intensive Monitoring CEA

Study type: Interventional

Funder types: Other

Identifiers

NCT00995202

EU-20979

2009-A00536-51

FFCD-PRODIGE-13

PRODIGE 13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,997 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,997 participants in 4 patient groups

Standard Monitoring CEA/ Standard Imagery

Other group

Description:

No specific follow-up of CEA and Standard imagery

Treatment:

Procedure: Standard Monitoring Imagery

Procedure: Standard Monitoring CEA

Intensive monitoring CEA/ Standard Imagery

Other group

Description:

Intensive follow-up CEA and Standard imagery .

Treatment:

Procedure: Intensive Monitoring CEA

Procedure: Standard Monitoring Imagery

Intensive Monitoring CEA / Intensive Monitoring Imagery

Other group

Description:

Intensive follow-up CEA and Intensive imagery

Treatment:

Procedure: Intensive Monitoring CEA

Procedure: Intensive Monitoring Imagery

Standard Monitoring CEA/ Intensive Monitoring Imagery

Other group

Description:

No specific follow-up of CEA and Intensive Imagery

Treatment:

Procedure: Intensive Monitoring Imagery

Procedure: Standard Monitoring CEA