Clinical trial NCT00995202: Follow-Up Care With or Without CEA Assessments in Patients Who Have Undergone Surgery for Stage II or Stage III Colorectal Cancer
Official title: Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Federation Francophone de Cancerologie Digestive
Sponsor class: OTHER
First posted: 2009-10-15
Enrollment: 1997
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study is a surveillance study not an interventional study with products
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Overall survival rate
timeFrame: 5 years
Secondary outcomes:
measure: Disease-free survival rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Arlon
country: Belgium
facility: Clinique Sud Luxembourg
city: Abbeville
country: France
facility: CH
city: Abbeville
country: France
facility: Clinique Isabelle
city: Amiens
country: France
facility: CHU Nord
city: Angers
country: France
facility: CHU
city: Antibes
country: France
facility: CH
city: Aubenas
country: France
facility: CH
city: Auch
country: France
facility: CH
city: Auxerre
country: France
facility: CH
city: Auxerre
country: France
facility: Polyclinique Ste Marguerite
city: Avignon
country: France
facility: CH Henri Duffaut
city: Avignon
country: France
facility: Clinique Sainte Cahterine
city: Bayonne
country: France
facility: Centre d'oncologie et de radiothérapie du Pays Basque
city: Beaune
country: France
facility: CH
city: Beauvais
country: France
facility: CH
city: Besançon
country: France
facility: CHU J Minjoz
city: Blois
country: France
facility: CH
city: Bobigny
country: France
facility: CH
city: Bordeaux
country: France
facility: Polyclinique Nord Aquitaine
city: Boulogne Sur Mer
country: France
facility: CH Duchenne
city: Bourg en Bresse
country: France
facility: CH
city: Brest
country: France
facility: Hôpital du Morvan
city: Briey
country: France
facility: CH
city: Béziers
country: France
facility: Centre de Radiothérapie et d'oncologie médicale
city: Béziers
country: France
facility: CH
city: Castres
country: France
facility: CHIC
city: Challans
country: France
facility: CH
city: Chalon sur Saone
country: France
facility: Hôpital Sainte Marie
city: Chambery
country: France
facility: CH
city: Chambery
country: France
facility: Clinique du Cléret et Clinique Saint Joseph
city: Cholet
country: France
facility: CH
city: Châlons en Champagne
country: France
facility: CH
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Colmar
country: France
facility: Hôpital Pästeur
city: Compiegne
country: France
facility: CH
city: Coquelles
country: France
facility: Clinique des 2 Caps
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Cucq
country: France
facility: Clinique des Acacias
city: Dax
country: France
facility: CH
city: Dijon
country: France
facility: Cabinet d'HGE - Cours De Gaulle
city: Dijon
country: France
facility: Cabinet Privé Point Médical
city: Dijon
country: France
facility: Centre d'Oncologie Médicale du Parc
city: Dijon
country: France
facility: CHU le bocage
city: Draguignan
country: France
facility: CH
city: Epernay
country: France
facility: Clinique Saint Vincent
city: Ferolles Attilly
country: France
facility: Centre médical de Forcilles
city: Frejus
country: France
facility: CHI Saint Raphael
city: Gap
country: France
facility: CHI
city: Grenoble
country: France
facility: Institut Hollard
city: Haguenau
country: France
facility: CH
city: La Roche sur Yon
country: France
facility: CHD
city: Lagny sur Marne
country: France
facility: CH
city: Le Coudray
country: France
facility: CH Louis Pasteur
city: Le Havre
country: France
facility: CH
city: Le Mans
country: France
facility: CH
city: Libourne
country: France
facility: Hôpital Robert Boulin
city: Lille
country: France
facility: Centre Oscar Lambret
city: Longjumeau
country: France
facility: CHG
city: Lormont
country: France
facility: Clinique des 4 pavillons
city: Lyon
country: France
facility: CHU Lyon Sud
city: Macon
country: France
facility: CH
city: Macon
country: France
facility: Polyclinique du Val de Saône
city: Marseille
country: France
facility: CH Saint Joseph
city: Marseille
country: France
facility: CHU La Timone
city: Marseille
country: France
facility: Hôpital Européen
city: Marseille
country: France
facility: Hôpital Nord
city: Mont de Marsan
country: France
facility: Hôpital Layné
city: Montbrison
country: France
facility: CH
city: Montceau Les Mines
country: France
facility: CH
city: Montelimar
country: France
facility: CH
city: Montfermeil
country: France
facility: CHI Le Raincy Montfermeil
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Neuilly-Sur-Seine
country: France
facility: Hopital Americain de Paris
city: Nevers
country: France
facility: Polyclinique Val de Loire
city: Nice
country: France
facility: Hôpital l'Archet II
city: Nimes
country: France
facility: CHU Carémeau
city: Nimes
country: France
facility: Clinique Valdegour
city: Orléans
country: France
facility: CHR - Sce D'HGE
city: Orléans
country: France
facility: CHR - Sce d'Oncologie
city: Paris
country: France
facility: Hôpital Privé Les Peupliers
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pau
country: France
facility: CH
city: Perigueux
country: France
facility: Polyclinique Francheville
city: Perpignan
country: France
facility: Centre Catalan d'Oncologie
city: Perpignan
country: France
facility: Hôpital Saint Jean
city: Pessac
country: France
facility: CHU Haut Lévèque
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Privas
country: France
facility: CH
city: Reims
country: France
facility: CHU Robert Debré
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rodez
country: France
facility: CH
city: Romans-Sur-Isère
country: France
facility: CH Romans
city: Saint Brieuc
country: France
facility: CH Yves Lefoll
city: Saint Chamond
country: France
facility: CHPG
city: Saint Die Des Vosges
country: France
facility: CH
city: Saint Jean De Luz
country: France
facility: Polyclinique Côte Basque Sud
city: Saint Martin Boulogne
country: France
facility: Centre Joliot Curie
city: Saint Martin Boulogne
country: France
facility: Clinique de la Côte d'Opale
city: Saint Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire - Cité Sanitaire
city: Saint-Etienne
country: France
facility: CHU
city: Saint-Malo
country: France
facility: Hôpital Broussais
city: Sainte-Colombe
country: France
facility: Clinique
city: Sainte-Feyre
country: France
facility: Centre Médical National MGEN Alfred Leune
city: Semur en Auxois
country: France
facility: CH
city: Soissons
country: France
facility: CH
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulon
country: France
facility: Hôpital Sainte Musse
city: Tourcoing
country: France
facility: CH Gustave Dron
city: Tours
country: France
facility: CH Trousseau
city: Valence
country: France
facility: CH
city: Vannes
country: France
facility: CHBA
city: Vernon
country: France
facility: CH
city: Vesoul
country: France
facility: CH
city: Villeneuve D'Ascq
country: France
facility: CH Privé
city: Villeneuve Saint-Georges
country: France
facility: CH
city: Fort-de-France
country: Martinique
facility: CHU Clarac
Study officials:
affiliation: Centre Hospitalier Universitaire Dijon
name: Come Lepage, Pr
role: PRINCIPAL_INVESTIGATOR
References:
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.