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
4 other identifiers
interventional
1,997
3 countries
117
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Sep 2009
Longer than P75 for phase_3 colorectal-cancer
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 14, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedDecember 7, 2021
December 1, 2021
10.3 years
October 14, 2009
December 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival rate
Time between randomization and date of death (all causes)
5 years
Secondary Outcomes (1)
Disease-free survival rate
5 years
Study Arms (4)
Standard Monitoring CEA/ Standard Imagery
OTHERNo specific follow-up of CEA and Standard imagery
Intensive monitoring CEA/ Standard Imagery
OTHERIntensive follow-up CEA and Standard imagery .
Intensive Monitoring CEA / Intensive Monitoring Imagery
OTHERIntensive follow-up CEA and Intensive imagery
Standard Monitoring CEA/ Intensive Monitoring Imagery
OTHERNo specific follow-up of CEA and Intensive Imagery
Interventions
No specific follow-up of CEA
CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.
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
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
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (117)
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
Related Publications (1)
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.
PMID: 25933809BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Come Lepage, Pr
Centre Hospitalier Universitaire Dijon
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2009
First Posted
October 15, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2019
Study Completion
June 1, 2021
Last Updated
December 7, 2021
Record last verified: 2021-12