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

Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Standard Monitoring CEA; Procedure: Standard Monitoring Imagery; Procedure: Intensive Monitoring CEA; Procedure: Intensive Monitoring Imagery

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 Type: Interventional
• Enrollment (Actual): 1997
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Arlon, Belgium
    • Clinique Sud Luxembourg
• France
  • Abbeville, France
    • CH
  • Abbeville, France
    • Clinique Isabelle
  • Amiens, France
    • CHU Nord
  • Angers, France
    • CHU
  • Antibes, France
    • CH
  • Aubenas, France
    • CH
  • Auch, France
    • CH
  • Auxerre, France
    • CH
  • Auxerre, France
    • Polyclinique Ste Marguerite
  • Avignon, France
    • CH Henri Duffaut
  • Avignon, France
    • Clinique Sainte Cahterine
  • Bayonne, France
    • Centre d'oncologie et de radiothérapie du Pays Basque
  • Beaune, France
    • CH
  • Beauvais, France
    • CH
  • Besançon, France
    • CHU J Minjoz
  • Blois, France
    • CH
  • Bobigny, France
    • CH
  • Bordeaux, France
    • Polyclinique Nord Aquitaine
  • Boulogne Sur Mer, France
    • CH Duchenne
  • Bourg en Bresse, France
    • CH
  • Brest, France
    • Hôpital du Morvan
  • Briey, France
    • CH
  • Béziers, France
    • CH
  • Béziers, France
    • Centre de Radiothérapie et d'oncologie médicale
  • Castres, France
    • CHIC
  • Challans, France
    • CH
  • Chalon sur Saone, France
    • Hôpital Sainte Marie
  • Chambery, France
    • CH
  • Chambery, France
    • Clinique du Cléret et Clinique Saint Joseph
  • Cholet, France
    • CH
  • Châlons en Champagne, France
    • CH
  • Clermont Ferrand, France
    • CHU Estaing
  • Colmar, France
    • Hôpital Pasteur
  • Compiegne, France
    • CH
  • Coquelles, France
    • Clinique Des 2 Caps
  • Cornebarrieu, France
    • Clinique des Cèdres
  • Cucq, France
    • Clinique des Acacias
  • Dax, France
    • CH
  • Dijon, France
    • CHU Le Bocage
  • Dijon, France
    • Cabinet d'HGE - Cours De Gaulle
  • Dijon, France
    • Cabinet Privé Point Médical
  • Dijon, France
    • Centre d'Oncologie Médicale du Parc
  • Draguignan, France
    • CH
  • Epernay, France
    • Clinique Saint Vincent
  • Ferolles Attilly, France
    • Centre médical de Forcilles
  • Frejus, France
    • CHI Saint Raphael
  • Gap, France
    • CHI
  • Grenoble, France
    • Institut Hollard
  • Haguenau, France
    • CH
  • La Roche sur Yon, France
    • CHD
  • Lagny sur Marne, France
    • CH
  • Le Coudray, France
    • CH Louis Pasteur
  • Le Havre, France
    • CH
  • Le Mans, France
    • CH
  • Libourne, France
    • Hôpital Robert Boulin
  • Lille, France
    • Centre Oscar Lambret
  • Longjumeau, France
    • CHG
  • Lormont, France
    • Clinique des 4 Pavillons
  • Lyon, France
    • CHU Lyon Sud
  • Macon, France
    • CH
  • Macon, France
    • Polyclinique du Val de Saône
  • Marseille, France
    • CHU La Timone
  • Marseille, France
    • Hôpital Européen
  • Marseille, France
    • Hopital Nord
  • Marseille, France
    • CH Saint Joseph
  • Mont de Marsan, France
    • Hôpital Layne
  • Montbrison, France
    • CH
  • Montceau Les Mines, France
    • CH
  • Montelimar, France
    • CH
  • Montfermeil, France
    • CHI Le Raincy Montfermeil
  • Mougins, France
    • Centre Azureen de Cancerologie
  • Neuilly-Sur-Seine, France
    • Hôpital Américain de Paris
  • Nevers, France
    • Polyclinique Val de Loire
  • Nice, France
    • Hopital L'Archet II
  • Nimes, France
    • CHU Caremeau
  • Nimes, France
    • Clinique Valdegour
  • Orléans, France
    • CHR - Sce D'HGE
  • Orléans, France
    • CHR - Sce d'Oncologie
  • Paris, France
    • Hopital Saint Louis
  • Paris, France
    • Hôpital Privé Les Peupliers
  • Pau, France
    • CH
  • Perigueux, France
    • Polyclinique Francheville
  • Perpignan, France
    • Centre Catalan d'Oncologie
  • Perpignan, France
    • Hopital Saint Jean
  • Pessac, France
    • CHU Haut Leveque
  • Pringy, France
    • Centre Hospitalier Annecy Genevois
  • Privas, France
    • CH
  • Reims, France
    • CHU Robert Debré
  • Reims, France
    • Institut Jean Godinot
  • Rennes, France
    • CHU Pontchaillou
  • Rodez, France
    • CH
  • Romans-Sur-Isère, France
    • CH Romans
  • Saint Brieuc, France
    • CH Yves Lefoll
  • Saint Chamond, France
    • CHPG
  • Saint Die Des Vosges, France
    • CH
  • Saint Jean De Luz, France
    • Polyclinique Côte Basque Sud
  • Saint Martin Boulogne, France
    • Centre Joliot Curie
  • Saint Martin Boulogne, France
    • Clinique de la Côte d'Opale
  • Saint Nazaire, France
    • Clinique Mutualiste de l'Estuaire - Cité Sanitaire
  • Saint-Etienne, France
    • CHU
  • Saint-Malo, France
    • Hôpital Broussais
  • Sainte-Colombe, France
    • Clinique
  • Sainte-Feyre, France
    • Centre Médical National MGEN Alfred Leune
  • Semur en Auxois, France
    • CH
  • Soissons, France
    • CH
  • Strasbourg, France
    • Centre PAUL STRAUSS
  • Toulon, France
    • Hôpital Sainte Musse
  • Tourcoing, France
    • CH Gustave Dron
  • Tours, France
    • Ch Trousseau
  • Valence, France
    • CH
  • Vannes, France
    • CHBA
  • Vernon, France
    • CH
  • Vesoul, France
    • CH
  • Villeneuve D'Ascq, France
    • CH Privé
  • Villeneuve Saint-Georges, France
    • CH
• Martinique
  • Fort-de-France, Martinique
    • CHU Clarac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: Intensive monitoring CEA/ Standard Imagery; Intensive follow-up CEA and Standard imagery .	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; Procedure: Intensive Monitoring CEA; CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival rate	Time between randomization and date of death (all causes)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival rate	Time between randomization and first recurrence (local or metastatic) or death (all causes)	5 years

Collaborators and Investigators

• Sponsor: Federation Francophone de Cancerologie Digestive
• Investigators: Principal Investigator: Come Lepage, Pr, Centre Hospitalier Universitaire Dijon

Publications and helpful links

General Publications

• Lepage C, Phelip JM, Cany L, Faroux R, Manfredi S, Ain JF, Pezet D, Baconnier M, Deguiral P, Terrebone E, Adenis A, Le Malicot K, Bedenne L, Bouche O. Effect of 5 years of imaging and CEA follow-up to detect recurrence of colorectal cancer: The FFCD PRODIGE 13 randomised phase III trial. Dig Liver Dis. 2015 Jul;47(7):529-31. doi: 10.1016/j.dld.2015.03.021. Epub 2015 Apr 2. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2009
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: October 14, 2009
• First Submitted That Met QC Criteria: October 14, 2009
• First Posted (Estimate): October 15, 2009

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; adenocarcinoma of the colon; stage III colon cancer; stage II rectal cancer; stage III rectal cancer; stage II colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PRODIGE 13; FFCD-PRODIGE-13; 2009-A00536-51; EU-20979