Back to resultsFollow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer (SURVEILLANCE)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Standard Monitoring CEA
Intensive Monitoring CEA
Standard Monitoring Imagery
Intensive Monitoring Imagery
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring stage II colon cancer, stage II rectal cancer, stage III colon cancer, stage III rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
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
Sites / Locations
- Clinique Sud Luxembourg
- CH
- Clinique Isabelle
- CHU Nord
- CHU
- CH
- CH
- CH
- CH
- Polyclinique Ste Marguerite
- CH Henri Duffaut
- Clinique Sainte Cahterine
- Centre d'oncologie et de radiothérapie du Pays Basque
- CH
- CH
- CHU J Minjoz
- CH
- CH
- Polyclinique Nord Aquitaine
- CH Duchenne
- CH
- Hôpital du Morvan
- CH
- Centre de Radiothérapie et d'oncologie médicale
- CH
- CHIC
- CH
- Hôpital Sainte Marie
- CH
- Clinique du Cléret et Clinique Saint Joseph
- CH
- CH
- CHU Estaing
- Hôpital Pästeur
- CH
- Clinique des 2 Caps
- Clinique des Cèdres
- Clinique des Acacias
- CH
- Cabinet d'HGE - Cours De Gaulle
- Cabinet Privé Point Médical
- Centre d'Oncologie Médicale du Parc
- CHU le bocage
- CH
- Clinique Saint Vincent
- Centre médical de Forcilles
- CHI Saint Raphael
- CHI
- Institut Hollard
- CH
- CHD
- CH
- CH Louis Pasteur
- CH
- CH
- Hôpital Robert Boulin
- Centre Oscar Lambret
- CHG
- Clinique des 4 pavillons
- CHU Lyon Sud
- CH
- Polyclinique du Val de Saône
- CH Saint Joseph
- CHU La Timone
- Hôpital Européen
- Hôpital Nord
- Hôpital Layné
- CH
- CH
- CH
- CHI Le Raincy Montfermeil
- Centre Azuréen de Cancérologie
- Hopital Americain de Paris
- Polyclinique Val de Loire
- Hôpital l'Archet II
- CHU Carémeau
- Clinique Valdegour
- CHR - Sce D'HGE
- CHR - Sce d'Oncologie
- Hôpital Privé Les Peupliers
- Hôpital Saint Louis
- CH
- Polyclinique Francheville
- Centre Catalan d'Oncologie
- Hôpital Saint Jean
- CHU Haut Lévèque
- Centre Hospitalier Annecy Genevois
- CH
- CHU Robert Debré
- Institut Jean Godinot
- CHU Pontchaillou
- CH
- CH Romans
- CH Yves Lefoll
- CHPG
- CH
- Polyclinique Côte Basque Sud
- Centre Joliot Curie
- Clinique de la Côte d'Opale
- Clinique Mutualiste de l'Estuaire - Cité Sanitaire
- CHU
- Hôpital Broussais
- Clinique
- Centre Médical National MGEN Alfred Leune
- CH
- CH
- Centre Paul Strauss
- Hôpital Sainte Musse
- CH Gustave Dron
- CH Trousseau
- CH
- CHBA
- CH
- CH
- CH Privé
- CH
- CHU Clarac
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Standard Monitoring CEA/ Standard Imagery
Intensive monitoring CEA/ Standard Imagery
Intensive Monitoring CEA / Intensive Monitoring Imagery
Standard Monitoring CEA/ Intensive Monitoring Imagery
Arm Description
No specific follow-up of CEA and Standard imagery
Intensive follow-up CEA and Standard imagery .
Intensive follow-up CEA and Intensive imagery
No specific follow-up of CEA and Intensive Imagery
Outcomes
Primary Outcome Measures
Overall survival rate
Time between randomization and date of death (all causes)
Secondary Outcome Measures
Disease-free survival rate
Time between randomization and first recurrence (local or metastatic) or death (all causes)
Full Information
NCT ID
NCT00995202
First Posted
October 14, 2009
Last Updated
December 6, 2021
Sponsor
Federation Francophone de Cancerologie Digestive
1. Study Identification
Unique Protocol Identification Number
NCT00995202
Brief Title
Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer
Acronym
SURVEILLANCE
Official Title
Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
June 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage II colon cancer, stage II rectal cancer, stage III colon cancer, stage III rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Model Description
This study is a surveillance study not an interventional study with products
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1997 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Monitoring CEA/ Standard Imagery
Arm Type
Other
Arm Description
No specific follow-up of CEA and Standard imagery
Arm Title
Intensive monitoring CEA/ Standard Imagery
Arm Type
Other
Arm Description
Intensive follow-up CEA and Standard imagery .
Arm Title
Intensive Monitoring CEA / Intensive Monitoring Imagery
Arm Type
Other
Arm Description
Intensive follow-up CEA and Intensive imagery
Arm Title
Standard Monitoring CEA/ Intensive Monitoring Imagery
Arm Type
Other
Arm Description
No specific follow-up of CEA and Intensive Imagery
Intervention Type
Procedure
Intervention Name(s)
Standard Monitoring CEA
Intervention Description
No specific follow-up of CEA
Intervention Type
Procedure
Intervention Name(s)
Intensive Monitoring CEA
Intervention Description
CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.
Intervention Type
Procedure
Intervention Name(s)
Standard Monitoring Imagery
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Intensive Monitoring Imagery
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall survival rate
Description
Time between randomization and date of death (all causes)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease-free survival rate
Description
Time between randomization and first recurrence (local or metastatic) or death (all causes)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Come Lepage, Pr
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Sud Luxembourg
City
Arlon
Country
Belgium
Facility Name
CH
City
Abbeville
Country
France
Facility Name
Clinique Isabelle
City
Abbeville
Country
France
Facility Name
CHU Nord
City
Amiens
Country
France
Facility Name
CHU
City
Angers
Country
France
Facility Name
CH
City
Antibes
Country
France
Facility Name
CH
City
Aubenas
Country
France
Facility Name
CH
City
Auch
Country
France
Facility Name
CH
City
Auxerre
Country
France
Facility Name
Polyclinique Ste Marguerite
City
Auxerre
Country
France
Facility Name
CH Henri Duffaut
City
Avignon
Country
France
Facility Name
Clinique Sainte Cahterine
City
Avignon
Country
France
Facility Name
Centre d'oncologie et de radiothérapie du Pays Basque
City
Bayonne
Country
France
Facility Name
CH
City
Beaune
Country
France
Facility Name
CH
City
Beauvais
Country
France
Facility Name
CHU J Minjoz
City
Besançon
Country
France
Facility Name
CH
City
Blois
Country
France
Facility Name
CH
City
Bobigny
Country
France
Facility Name
Polyclinique Nord Aquitaine
City
Bordeaux
Country
France
Facility Name
CH Duchenne
City
Boulogne Sur Mer
Country
France
Facility Name
CH
City
Bourg en Bresse
Country
France
Facility Name
Hôpital du Morvan
City
Brest
Country
France
Facility Name
CH
City
Briey
Country
France
Facility Name
Centre de Radiothérapie et d'oncologie médicale
City
Béziers
Country
France
Facility Name
CH
City
Béziers
Country
France
Facility Name
CHIC
City
Castres
Country
France
Facility Name
CH
City
Challans
Country
France
Facility Name
Hôpital Sainte Marie
City
Chalon sur Saone
Country
France
Facility Name
CH
City
Chambery
Country
France
Facility Name
Clinique du Cléret et Clinique Saint Joseph
City
Chambery
Country
France
Facility Name
CH
City
Cholet
Country
France
Facility Name
CH
City
Châlons en Champagne
Country
France
Facility Name
CHU Estaing
City
Clermont Ferrand
Country
France
Facility Name
Hôpital Pästeur
City
Colmar
Country
France
Facility Name
CH
City
Compiegne
Country
France
Facility Name
Clinique des 2 Caps
City
Coquelles
Country
France
Facility Name
Clinique des Cèdres
City
Cornebarrieu
Country
France
Facility Name
Clinique des Acacias
City
Cucq
Country
France
Facility Name
CH
City
Dax
Country
France
Facility Name
Cabinet d'HGE - Cours De Gaulle
City
Dijon
Country
France
Facility Name
Cabinet Privé Point Médical
City
Dijon
Country
France
Facility Name
Centre d'Oncologie Médicale du Parc
City
Dijon
Country
France
Facility Name
CHU le bocage
City
Dijon
Country
France
Facility Name
CH
City
Draguignan
Country
France
Facility Name
Clinique Saint Vincent
City
Epernay
Country
France
Facility Name
Centre médical de Forcilles
City
Ferolles Attilly
Country
France
Facility Name
CHI Saint Raphael
City
Frejus
Country
France
Facility Name
CHI
City
Gap
Country
France
Facility Name
Institut Hollard
City
Grenoble
Country
France
Facility Name
CH
City
Haguenau
Country
France
Facility Name
CHD
City
La Roche sur Yon
Country
France
Facility Name
CH
City
Lagny sur Marne
Country
France
Facility Name
CH Louis Pasteur
City
Le Coudray
Country
France
Facility Name
CH
City
Le Havre
Country
France
Facility Name
CH
City
Le Mans
Country
France
Facility Name
Hôpital Robert Boulin
City
Libourne
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
CHG
City
Longjumeau
Country
France
Facility Name
Clinique des 4 pavillons
City
Lormont
Country
France
Facility Name
CHU Lyon Sud
City
Lyon
Country
France
Facility Name
CH
City
Macon
Country
France
Facility Name
Polyclinique du Val de Saône
City
Macon
Country
France
Facility Name
CH Saint Joseph
City
Marseille
Country
France
Facility Name
CHU La Timone
City
Marseille
Country
France
Facility Name
Hôpital Européen
City
Marseille
Country
France
Facility Name
Hôpital Nord
City
Marseille
Country
France
Facility Name
Hôpital Layné
City
Mont de Marsan
Country
France
Facility Name
CH
City
Montbrison
Country
France
Facility Name
CH
City
Montceau Les Mines
Country
France
Facility Name
CH
City
Montelimar
Country
France
Facility Name
CHI Le Raincy Montfermeil
City
Montfermeil
Country
France
Facility Name
Centre Azuréen de Cancérologie
City
Mougins
Country
France
Facility Name
Hopital Americain de Paris
City
Neuilly-Sur-Seine
Country
France
Facility Name
Polyclinique Val de Loire
City
Nevers
Country
France
Facility Name
Hôpital l'Archet II
City
Nice
Country
France
Facility Name
CHU Carémeau
City
Nimes
Country
France
Facility Name
Clinique Valdegour
City
Nimes
Country
France
Facility Name
CHR - Sce D'HGE
City
Orléans
Country
France
Facility Name
CHR - Sce d'Oncologie
City
Orléans
Country
France
Facility Name
Hôpital Privé Les Peupliers
City
Paris
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Facility Name
CH
City
Pau
Country
France
Facility Name
Polyclinique Francheville
City
Perigueux
Country
France
Facility Name
Centre Catalan d'Oncologie
City
Perpignan
Country
France
Facility Name
Hôpital Saint Jean
City
Perpignan
Country
France
Facility Name
CHU Haut Lévèque
City
Pessac
Country
France
Facility Name
Centre Hospitalier Annecy Genevois
City
Pringy
Country
France
Facility Name
CH
City
Privas
Country
France
Facility Name
CHU Robert Debré
City
Reims
Country
France
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
Country
France
Facility Name
CH
City
Rodez
Country
France
Facility Name
CH Romans
City
Romans-Sur-Isère
Country
France
Facility Name
CH Yves Lefoll
City
Saint Brieuc
Country
France
Facility Name
CHPG
City
Saint Chamond
Country
France
Facility Name
CH
City
Saint Die Des Vosges
Country
France
Facility Name
Polyclinique Côte Basque Sud
City
Saint Jean De Luz
Country
France
Facility Name
Centre Joliot Curie
City
Saint Martin Boulogne
Country
France
Facility Name
Clinique de la Côte d'Opale
City
Saint Martin Boulogne
Country
France
Facility Name
Clinique Mutualiste de l'Estuaire - Cité Sanitaire
City
Saint Nazaire
Country
France
Facility Name
CHU
City
Saint-Etienne
Country
France
Facility Name
Hôpital Broussais
City
Saint-Malo
Country
France
Facility Name
Clinique
City
Sainte-Colombe
Country
France
Facility Name
Centre Médical National MGEN Alfred Leune
City
Sainte-Feyre
Country
France
Facility Name
CH
City
Semur en Auxois
Country
France
Facility Name
CH
City
Soissons
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Facility Name
Hôpital Sainte Musse
City
Toulon
Country
France
Facility Name
CH Gustave Dron
City
Tourcoing
Country
France
Facility Name
CH Trousseau
City
Tours
Country
France
Facility Name
CH
City
Valence
Country
France
Facility Name
CHBA
City
Vannes
Country
France
Facility Name
CH
City
Vernon
Country
France
Facility Name
CH
City
Vesoul
Country
France
Facility Name
CH Privé
City
Villeneuve D'Ascq
Country
France
Facility Name
CH
City
Villeneuve Saint-Georges
Country
France
Facility Name
CHU Clarac
City
Fort-de-France
Country
Martinique
12. IPD Sharing Statement
Citations:
PubMed Identifier
25933809
Citation
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.
Results Reference
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Learn more about this trial
Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer
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