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

Colorectal Cancer Clinical Trial

— SURVEILLANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995202
• Other study ID #: PRODIGE 13
• Secondary ID: FFCD-PRODIGE-132
• Status: Completed
• Phase: Phase 3
• Start date: September 2009
• Est. completion date: June 2021

Study information

• Verified date: December 2021
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1997
• Est. completion date: June 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Belgium	Clinique Sud Luxembourg	Arlon
France	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 Saone
France	CH	Châlons en Champagne
France	CH	Chambery
France	Clinique du Cléret et Clinique Saint Joseph	Chambery
France	CH	Cholet
France	CHU Estaing	Clermont Ferrand
France	Hôpital Pästeur	Colmar
France	CH	Compiegne
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	Epernay
France	Centre médical de Forcilles	Ferolles Attilly
France	CHI Saint Raphael	Frejus
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	Macon
France	Polyclinique du Val de Saône	Macon
France	CH Saint Joseph	Marseille
France	CHU La Timone	Marseille
France	Hôpital Européen	Marseille
France	Hôpital Nord	Marseille
France	Hôpital Layné	Mont de Marsan
France	CH	Montbrison
France	CH	Montceau Les Mines
France	CH	Montelimar
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	Nimes
France	Clinique Valdegour	Nimes
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	Polyclinique Francheville	Perigueux
France	Centre Catalan d'Oncologie	Perpignan
France	Hôpital Saint Jean	Perpignan
France	CHU Haut Lévèque	Pessac
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 Die Des Vosges
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	CHU	Saint-Etienne
France	Hôpital Broussais	Saint-Malo
France	Clinique	Sainte-Colombe
France	Centre Médical National MGEN Alfred Leune	Sainte-Feyre
France	CH	Semur en Auxois
France	CH	Soissons
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
Martinique	CHU Clarac	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Countries where clinical trial is conducted

Belgium,  France,  Martinique, 

References & 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, Bouché 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	Time between randomization and date of death (all causes)	5 years
Secondary	Disease-free survival rate	Time between randomization and first recurrence (local or metastatic) or death (all causes)	5 years