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| ID | Type | Description | Link |
|---|---|---|---|
| FFCD-PRODIGE-13 | |||
| 2009-A00536-51 | |||
| EU-20979 |
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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.
OBJECTIVES:
OUTLINE: This is a multinational/multicenter study. Patients are randomized to 1 of 2 follow-up arms.
Patients undergo a second randomization to 1 of 2 follow-up arms at the beginning of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Monitoring CEA/ Standard Imagery | Other | No specific follow-up of CEA and Standard imagery |
|
| Intensive monitoring CEA/ Standard Imagery | Other | Intensive follow-up CEA and Standard imagery . |
|
| Intensive Monitoring CEA / Intensive Monitoring Imagery | Other | Intensive follow-up CEA and Intensive imagery |
|
| Standard Monitoring CEA/ Intensive Monitoring Imagery | Other | No specific follow-up of CEA and Intensive Imagery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Monitoring CEA | Procedure | No specific follow-up of CEA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | Time between randomization and date of death (all causes) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival rate | Time between randomization and first recurrence (local or metastatic) or death (all causes) | 5 years |
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DISEASE CHARACTERISTICS:
Pathologically confirmed adenocarcinoma of the colon or rectum
Has undergone curative resection for no residual tumor
Carcinoembryonic antigen (CEA) ≤ 1.5 x upper limit of normal after surgery
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Come Lepage, Pr | Centre Hospitalier Universitaire Dijon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Sud Luxembourg | Arlon | Belgium | ||||
| CH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25933809 | Background | 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. | |
| 42100890 |
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This study is a surveillance study not an interventional study with products
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| Intensive Monitoring CEA | Procedure | CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years. |
|
| Standard Monitoring Imagery | Procedure | 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 | Procedure | 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 |
|
| 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 |
| Derived |
| Lecuelle J, Truntzer C, Basile D, Laghi L, Greco L, Ilie A, Rageot D, Huppe T, Emile JF, Bibeau F, Taieb J, Derangere V, Lepage C, Ghiringhelli F. Deep learning based on CD3 histological slides for prediction of colon cancer outcome: analysis of three international stage III colon cancer cohorts. Oncoimmunology. 2026 Dec 31;15(1):2668797. doi: 10.1080/2162402X.2026.2668797. Epub 2026 May 8. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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