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Colorectal CancerPhase 3SURVEILLANCENCT00995202

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

A Phase 3 study testing Standard Monitoring CEA, Intensive Monitoring CEA and Standard Monitoring Imagery in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 117 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Standard Monitoring CEA, Intensive Monitoring CEA and Standard Monitoring Imagery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,997 participants
Where
117 sitesin 3 countries
Study dates
Sep 2009to Jun 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

117 sites in 3 countries.

117 sites in 3 countries

France115 sites

  • CH

    Abbeville

  • Clinique Isabelle

    Abbeville

  • CHU Nord

    Amiens

  • CHU

    Angers

  • CH

    Antibes

  • CH

    Aubenas

  • CH

    Auch

  • CH

    Auxerre

  • Polyclinique Ste Marguerite

    Auxerre

  • CH Henri Duffaut

    Avignon

  • Clinique Sainte Cahterine

    Avignon

  • Centre d'oncologie et de radiothérapie du Pays Basque

    Bayonne

  • CH

    Beaune

  • CH

    Beauvais

  • CHU J Minjoz

    Besançon

  • Centre de Radiothérapie et d'oncologie médicale

    Béziers

  • CH

    Béziers

  • CH

    Blois

  • CH

    Bobigny

  • Polyclinique Nord Aquitaine

    Bordeaux

  • CH Duchenne

    Boulogne-sur-Mer

  • CH

    Bourg-en-Bresse

  • Hôpital du Morvan

    Brest

  • CH

    Briey

  • CHIC

    Castres

  • CH

    Challans

  • Hôpital Sainte Marie

    Chalon-sur-Saône

  • CH

    Châlons-en-Champagne

  • CH

    Chambéry

  • Clinique du Cléret et Clinique Saint Joseph

    Chambéry

  • CH

    Cholet

  • CHU Estaing

    Clermont-Ferrand

  • Hôpital Pästeur

    Colmar

  • CH

    Compiègne

  • Clinique des 2 Caps

    Coquelles

  • Clinique des Cèdres

    Cornebarrieu

  • Clinique des Acacias

    Cucq

  • CH

    Dax

  • Cabinet d'HGE - Cours De Gaulle

    Dijon

  • Cabinet Privé Point Médical

    Dijon

  • Centre d'Oncologie Médicale du Parc

    Dijon

  • CHU le bocage

    Dijon

  • CH

    Draguignan

  • Clinique Saint Vincent

    Épernay

  • Centre médical de Forcilles

    Férolles-Attilly

  • CHI Saint Raphael

    Fréjus

  • CHI

    Gap

  • Institut Hollard

    Grenoble

  • CH

    Haguenau

  • CHD

    La Roche-sur-Yon

  • CH

    Lagny-sur-Marne

  • CH Louis Pasteur

    Le Coudray

  • CH

    Le Havre

  • CH

    Le Mans

  • Hôpital Robert Boulin

    Libourne

  • Centre Oscar Lambret

    Lille

  • CHG

    Longjumeau

  • Clinique des 4 pavillons

    Lormont

  • CHU Lyon Sud

    Lyon

  • CH

    Mâcon

  • Polyclinique du Val de Saône

    Mâcon

  • CH Saint Joseph

    Marseille

  • CHU La Timone

    Marseille

  • Hôpital Européen

    Marseille

  • Hôpital Nord

    Marseille

  • Hôpital Layné

    Mont-de-Marsan

  • CH

    Montbrison

  • CH

    Montceau-les-Mines

  • CH

    Montélimar

  • CHI Le Raincy Montfermeil

    Montfermeil

  • Centre Azuréen de Cancérologie

    Mougins

  • Hopital Americain de Paris

    Neuilly-sur-Seine

  • Polyclinique Val de Loire

    Nevers

  • Hôpital l'Archet II

    Nice

  • CHU Carémeau

    Nîmes

  • Clinique Valdegour

    Nîmes

  • CHR - Sce D'HGE

    Orléans

  • CHR - Sce d'Oncologie

    Orléans

  • Hôpital Privé Les Peupliers

    Paris

  • Hôpital Saint Louis

    Paris

  • CH

    Pau

  • Polyclinique Francheville

    Périgueux

  • Centre Catalan d'Oncologie

    Perpignan

  • Hôpital Saint Jean

    Perpignan

  • CHU Haut Lévèque

    Pessac

  • Centre Hospitalier Annecy Genevois

    Pringy

  • CH

    Privas

  • CHU Robert Debré

    Reims

  • Institut Jean Godinot

    Reims

  • CHU Pontchaillou

    Rennes

  • CH

    Rodez

  • CH Romans

    Romans-sur-Isère

  • CH Yves Lefoll

    Saint-Brieuc

  • CHPG

    Saint-Chamond

  • CH

    Saint-Dié

  • CHU

    Saint-Etienne

  • Polyclinique Côte Basque Sud

    Saint-Jean-de-Luz

  • Centre Joliot Curie

    Saint-Martin-Boulogne

  • Clinique de la Côte d'Opale

    Saint-Martin-Boulogne

  • Clinique Mutualiste de l'Estuaire - Cité Sanitaire

    Saint-Nazaire

  • Clinique

    Sainte-Colombe

  • Centre Médical National MGEN Alfred Leune

    Sainte-Feyre

  • CH

    Semur-en-Auxois

  • CH

    Soissons

  • Hôpital Broussais

    St-Malo

  • Centre Paul Strauss

    Strasbourg

  • Hôpital Sainte Musse

    Toulon

  • CH Gustave Dron

    Tourcoing

  • CH Trousseau

    Tours

  • CH

    Valence

  • CHBA

    Vannes

  • CH

    Vernon

  • CH

    Vesoul

  • CH Privé

    Villeneuve-d'Ascq

  • CH

    Villeneuve-Saint-Georges

Other trials in France

Belgium1 site

  • Clinique Sud Luxembourg

    Arlon

Other trials in Belgium

Martinique1 site

  • CHU Clarac

    Fort-de-France

Other trials in Martinique

About this study

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

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.

Read the 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.
Being tested
Standard Monitoring CEA, Intensive Monitoring CEA, Standard Monitoring Imagery, Intensive Monitoring Imagery
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
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Monitoring CEAProcedure or surgery

    No specific follow-up of CEA

  • Intensive Monitoring CEAProcedure or surgery

    CEA levels are measured every 3 months for 3 years, then every 6 months for 2 years.

  • Standard Monitoring ImageryProcedure or surgery

    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 ImageryProcedure or surgery

    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

Study groups in NCT00995202
Study groupRoleWhat they receive
Standard Monitoring CEA/ Standard ImageryOtherNo specific follow-up of CEA and Standard imagery
Receives: Procedure: Standard Monitoring CEA; Procedure: Standard Monitoring Imagery
Intensive monitoring CEA/ Standard ImageryOtherIntensive follow-up CEA and Standard imagery .
Receives: Procedure: Intensive Monitoring CEA; Procedure: Standard Monitoring Imagery
Intensive Monitoring CEA / Intensive Monitoring ImageryOtherIntensive follow-up CEA and Intensive imagery
Receives: Procedure: Intensive Monitoring CEA; Procedure: Intensive Monitoring Imagery
Standard Monitoring CEA/ Intensive Monitoring ImageryOtherNo specific follow-up of CEA and Intensive Imagery
Receives: Procedure: Standard Monitoring CEA; Procedure: Intensive Monitoring Imagery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival rate

    Time between randomization and date of death (all causes)

    Measured: 5 years

Secondary outcomes (1)

  1. Disease-free survival rate

    Time between randomization and first recurrence (local or metastatic) or death (all causes)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2019
  4. Study completionJun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
This study is a surveillance study not an interventional study with products
Masking
None (open label)
Enrolment
1,997 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00995202
Sponsor's protocol ID
PRODIGE 13
Other IDs
FFCD-PRODIGE-13, 2009-A00536-51, EU-20979
Acronym
SURVEILLANCE
Status last verified
Dec 2021
First submitted
14 Oct 2009
Last updated
7 Dec 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25933809

  • 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.

    PubMed 42100890

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Standard Monitoring CEA, Intensive Monitoring CEA and Standard Monitoring Imagery in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 117 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in France, Belgium, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00995202, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.

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