Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer
NCT ID: NCT00995202
Last Updated: 2021-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1997 participants
INTERVENTIONAL
2009-09-30
2021-06-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Standard Monitoring CEA/ Standard Imagery
No specific follow-up of CEA and Standard imagery
Standard Monitoring CEA
No specific follow-up of CEA
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 .
Intensive Monitoring CEA
CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.
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
Intensive Monitoring CEA
CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.
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
Standard Monitoring CEA
No specific follow-up of CEA
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
Interventions
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Standard Monitoring CEA
No specific follow-up of CEA
Intensive Monitoring CEA
CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.
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 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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Come Lepage, Pr
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Dijon
Locations
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Clinique Sud Luxembourg
Arlon, , Belgium
CH
Abbeville, , France
Clinique Isabelle
Abbeville, , France
CHU Nord
Amiens, , France
CHU
Angers, , France
CH
Antibes, , France
CH
Aubenas, , France
CH
Auch, , France
CH
Auxerre, , France
Polyclinique Ste Marguerite
Auxerre, , France
CH Henri Duffaut
Avignon, , France
Clinique Sainte Cahterine
Avignon, , France
Centre d'oncologie et de radiothérapie du Pays Basque
Bayonne, , France
CH
Beaune, , France
CH
Beauvais, , France
CHU J Minjoz
Besançon, , France
Centre de Radiothérapie et d'oncologie médicale
Béziers, , France
CH
Béziers, , France
CH
Blois, , France
CH
Bobigny, , France
Polyclinique Nord Aquitaine
Bordeaux, , France
CH Duchenne
Boulogne-sur-Mer, , France
CH
Bourg-en-Bresse, , France
Hôpital du Morvan
Brest, , France
CH
Briey, , France
CHIC
Castres, , France
CH
Challans, , France
Hôpital Sainte Marie
Chalon-sur-Saône, , France
CH
Chambéry, , France
Clinique du Cléret et Clinique Saint Joseph
Chambéry, , France
CH
Châlons-en-Champagne, , France
CH
Cholet, , France
CHU Estaing
Clermont-Ferrand, , France
Hôpital Pästeur
Colmar, , France
CH
Compiègne, , France
Clinique des 2 Caps
Coquelles, , France
Clinique des Cèdres
Cornebarrieu, , France
Clinique des Acacias
Cucq, , France
CH
Dax, , France
Cabinet d'HGE - Cours De Gaulle
Dijon, , France
Cabinet Privé Point Médical
Dijon, , France
Centre d'Oncologie Médicale du Parc
Dijon, , France
CHU le bocage
Dijon, , France
CH
Draguignan, , France
Clinique Saint Vincent
Épernay, , France
Centre médical de Forcilles
Férolles-Attilly, , France
CHI Saint Raphael
Fréjus, , France
CHI
Gap, , France
Institut Hollard
Grenoble, , France
CH
Haguenau, , France
CHD
La Roche-sur-Yon, , France
CH
Lagny-sur-Marne, , France
CH Louis Pasteur
Le Coudray, , France
CH
Le Havre, , France
CH
Le Mans, , France
Hôpital Robert Boulin
Libourne, , France
Centre Oscar Lambret
Lille, , France
CHG
Longjumeau, , France
Clinique des 4 pavillons
Lormont, , France
CHU Lyon Sud
Lyon, , France
CH Saint Joseph
Marseille, , France
CHU La Timone
Marseille, , France
Hôpital Européen
Marseille, , France
Hôpital Nord
Marseille, , France
CH
Mâcon, , France
Polyclinique du Val de Saône
Mâcon, , France
Hôpital Layné
Mont-de-Marsan, , France
CH
Montbrison, , France
CH
Montceau-les-Mines, , France
CH
Montélimar, , France
CHI Le Raincy Montfermeil
Montfermeil, , France
Centre Azuréen de Cancérologie
Mougins, , France
Hopital Americain de Paris
Neuilly-sur-Seine, , France
Polyclinique Val de Loire
Nevers, , France
Hôpital l'Archet II
Nice, , France
CHU Carémeau
Nîmes, , France
Clinique Valdegour
Nîmes, , France
CHR - Sce D'HGE
Orléans, , France
CHR - Sce d'Oncologie
Orléans, , France
Hôpital Privé Les Peupliers
Paris, , France
Hôpital Saint Louis
Paris, , France
CH
Pau, , France
Centre Catalan d'Oncologie
Perpignan, , France
Hôpital Saint Jean
Perpignan, , France
CHU Haut Lévèque
Pessac, , France
Polyclinique Francheville
Périgueux, , France
Centre Hospitalier Annecy Genevois
Pringy, , France
CH
Privas, , France
CHU Robert Debré
Reims, , France
Institut Jean Godinot
Reims, , France
CHU Pontchaillou
Rennes, , France
CH
Rodez, , France
CH Romans
Romans-sur-Isère, , France
CH Yves Lefoll
Saint-Brieuc, , France
CHPG
Saint-Chamond, , France
CH
Saint-Dié, , France
CHU
Saint-Etienne, , France
Polyclinique Côte Basque Sud
Saint-Jean-de-Luz, , France
Centre Joliot Curie
Saint-Martin-Boulogne, , France
Clinique de la Côte d'Opale
Saint-Martin-Boulogne, , France
Clinique Mutualiste de l'Estuaire - Cité Sanitaire
Saint-Nazaire, , France
Clinique
Sainte-Colombe, , France
Centre Médical National MGEN Alfred Leune
Sainte-Feyre, , France
CH
Semur-en-Auxois, , France
CH
Soissons, , France
Hôpital Broussais
St-Malo, , France
Centre Paul Strauss
Strasbourg, , France
Hôpital Sainte Musse
Toulon, , France
CH Gustave Dron
Tourcoing, , France
CH Trousseau
Tours, , France
CH
Valence, , France
CHBA
Vannes, , France
CH
Vernon, , France
CH
Vesoul, , France
CH Privé
Villeneuve-d'Ascq, , France
CH
Villeneuve-Saint-Georges, , France
CHU Clarac
Fort-de-France, , Martinique
Countries
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References
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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.
Other Identifiers
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FFCD-PRODIGE-13
Identifier Type: -
Identifier Source: secondary_id
2009-A00536-51
Identifier Type: -
Identifier Source: secondary_id
EU-20979
Identifier Type: -
Identifier Source: secondary_id
PRODIGE 13
Identifier Type: -
Identifier Source: org_study_id