AzTrials
AzTrials

OESOPHAGO-GASTRIC CARCINOMAPhase 3GASTFOXNCT03006432

PHASE III RANDOMISED TRIAL to EVALUATE FOLFOX with or WITHOUT DOCETAXEL (TFOX) AS 1st LINE CHEMOTHERAPY for LOCALLY ADVANCED or METASTATIC OESOPHAGO-GASTRIC CARCINOMA

A Phase 3 study testing Oxaliplatin, 5Fluorouracil bolus and 5Fluorouracil continu in people with OESOPHAGO-GASTRIC CARCINOMA, run by Federation Francophone de Cancerologie Digestive at 134 sites in 2 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

Gastric cancer is the fourth commonest cancer and the second largest cause of mortality from cancer. Surgical resection of localised forms of gastric cancer offers the only chance of a cure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
OESOPHAGO-GASTRIC CARCINOMA
What is being tested?
Oxaliplatin, 5Fluorouracil bolus and 5Fluorouracil continu
Could I receive a placebo?
No, everyone receives an active treatment
How many people
507 participants
Where
134 sitesin 2 countries
Study dates
19 Dec 2016to 27 Feb 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Gastric or gastro-oesophageal junction adenocarcinoma (all Siewert), histologically proven (on primary tumour or metastatic lesion),
  • HER2 negative (positive HER2 status is defined by a positive IHC test of 3+ or IHC of 2+ with positive FISH)
  • Metastatic or non-resectable (locally advanced) disease
  • Disease measurable according to RECIST v1.1 criteria (at least one measurable lesion)
  • No major surgical procedure during the 4 weeks prior to randomisation:
  • Patient eligible for a 1st line of chemotherapy based on 5FU, folinic acid and oxaliplatin (FOLFOX) with or without docetaxel (TFOX)
Show all 18Show fewer
  • WHO: 0-1
  • Age ≥ 18
  • BMI > 18
  • Life expectancy > 3 months
  • PNN > 1500/mm3, platelets > 100,000/mm3, Hb > 10 g/dL
  • AST, ALT ≤ 3.5 times the UNL, alkaline phosphatase < 6 times the UNL
  • Bilirubin ≤ 1.5 times the UNL,
  • Creatinine clearance according to Cockcroft and Gault formula > 50 mL/min
  • Women of childbearing age must have a negative pregnancy test (β HCG) before starting treatment
  • Women of childbearing age and men (who are in a sexual relationship with women of childbearing age) must agree to use effective contraception without interruption for the duration of the treatment and for 6 months after administration of the last dose of treatment
  • Patient affiliated to a social security scheme
  • Patient information and signature of informed consent form

Who cannot join

  • Presence of cerebral or meningeal metastases
  • Presence of > grade 2 neuropathy according to NCIC-CTC 4.0
  • Known DPD deficiency
  • QT/QTc interval > 450 msec for men and > 470 msec for women
  • K+ < LNL, Mg2+ < LNL, Ca2+ < LNL
  • Any known specific contraindication or allergy to the treatments used in the study (cf RCP Appendix 7)
Show all 17Show fewer
  • Chemotherapy or radio-chemotherapy in an adjuvant situation finished less than 12 months ago
  • Prior chemotherapy including oxaliplatin (except for adjuvant chemotherapy)
  • Prior chemotherapy including docetaxel
  • Any progressive pathology not stabilised over the past 6 months: liver impairment, renal impairment, respiratory or cardiac failure
  • HIV+ patients
  • Radiotherapy during the 4 weeks prior to randomisation
  • Other concomitant cancer or a history of cancer during the previous 5 years, with the exception of carcinoma in situ of the cervix or basal cell carcinoma or epidermoid cell carcinoma of the skin which is considered to be cured
  • Patient already included in another clinical trial involving an experimental drug
  • Pregnant or breastfeeding woman
  • Persons in custody or under wardship
  • Impossibility of undergoing medical monitoring during the trial for geographical, social or psychological reasons

Trial locations and contacts

134 sites in 2 countries.

134 sites in 2 countries

France132 sites

  • CH d'Abbeville

    Abbeville, 80142

  • CHU Amiens-Picardie

    Amiens

  • CHU d'Angers

    Angers, 49933

  • Hôpital Privé D'Antony

    Antony, 92166

  • Centre Hospitalier Victor Dupouy

    Argenteuil

  • CH d'Auxerre

    Auxerre, 89000

  • CH de la Côte Basque

    Bayonne

  • CH

    Beauvais

  • CH Germont et Gauthier

    Béthune, 62408

  • Centre Hospitalier Germon Et Gauthier

    Béthune

  • Centre de Radiothérapie Pierre Curie

    Beuvry, 62660

  • CH de Blois

    Blois, 41000

  • Clinique Tivoli

    Bordeaux, 33000

  • Institut Bergonie

    Bordeaux, 33076

  • Polyclinique de Bordeaux Nord

    Bordeaux, 33077

  • Polyclinique Saint Privat

    Boujan-sur-Libron, 34760

  • CMCO Côte d'Opale

    Boulogne-sur-Mer, 62222

  • Hôpital Duchenne

    Boulogne-sur-Mer

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse

  • Hôpital Pierre Oudot

    Bourgoin, 38300

  • Centre Hospitalier Pierre Oudot

    Bourgoin

  • CHU Côte de Nacre

    Caen, 14033

  • Infirmerie Protestante de Lyon

    Caluire-et-Cuire, 69300

  • Médipôle de Savoie

    Challes-les-Eaux, 73190

  • CH William Morey

    Chalon-sur-Saône, 71100

  • Centre Hospitalier William Morey

    Chalon-sur-Saône

  • Centre Hospitalier Général

    Châlons-en-Champagne, 51005

  • CH Metropole Savoie

    Chambéry

  • Hopital Prive Paul D Engine

    Champigny-sur-Marne

  • Hopitaux de Chartres, Centre Hospitalier Louis Pasteur

    Chartres

  • Centre Hospitalier de Cholet

    Cholet

  • Hopital D Instruction Des Armées Percy

    Clamart

  • Hopitaux civils de Colmar

    Colmar, 68024

  • Clinique Saint Côme

    Compiègne, 60204

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes

  • Clinique des Cèdres

    Cornebarrieu

  • Groupe Hospitalier Du Sud de L'Oise

    Creil

  • Hôpital Henri Mondor

    Créteil, 94000

  • CHI

    Créteil

  • Institut de Cancérologie de Bourgogne - GRRECC

    Dijon, 2100

  • Centre Georges-François Leclerc

    Dijon, 21079

  • CHU

    Dijon

  • Centre Hospitalier de Dinan

    Dinan

  • CHI Elbeuf-Louvier-Val de Reuil

    Elbeuf, 76503

  • Centre Hospitalier Intercommunal Elbeuf-Louviers/Val de Reuil

    Elbeuf

  • Hôpital Jacques Monod

    Flers, 61104

  • CHI de Fréjus Saint-Raphaël

    Fréjus, 83600

  • GHM Institut Daniel Hollard

    Grenoble, 38028

  • Chu Albert Michallon

    Grenoble

  • Hôpital privé Toulon/Hyères

    Hyères

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • CHU Grenoble - Hôpital Albert Michallon

    La Tronche, 38700

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay

  • Institut Hospitalier Franco-Britannique

    Levallois-Perret

  • Chu Claude Huriez

    Lille

  • Clinique François Chénieux

    Limoges, 87000

  • CHU Dupuytren

    Limoges, 87042

  • CH Longjumeau

    Longjumeau, 91160

  • Clinique de la Sauvegarde

    Lyon, 69009

  • CHU de Lyon - Croix Rousse

    Lyon, 69317

  • CH Saint Joseph - Saint Luc

    Lyon, 69365

  • Centre Léon Berard

    Lyon, 69373

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Hopital Saint Joseph -Saint Luc

    Lyon

  • Hôpital Privé Jean Mermoz

    Lyon

  • Centre Hospitalier Francois Quesnay

    Mantes-la-Jolie

  • CHU La Timone

    Marseille, 13385

  • Hôpital Nord

    Marseille, 13915

  • Association Hopital Saint Joseph de Marseille

    Marseille

  • Hôpital Européen

    Marseille

  • CH

    Meaux

  • Hopital Marc Jacquet

    Melun

  • Centre Hospitalier

    Montélimar, 26216

  • Ghi Le Raincy-Montfermeil

    Montfermeil

  • Hôpital Monod

    Montivilliers, 76290

  • Institut Régional du Cancer Montpellier

    Montpellier, 34298

  • Chu de Nancy

    Nancy

  • Hôpital privé du Confluent SAS

    Nantes, 44277

  • Chu de Nantes

    Nantes

  • CH Pierre Bérégovoy

    Nevers

  • CH de Niort

    Niort

  • CH Régional de la Source

    Orléans, 45067

  • Hôpital de la source

    Orléans, 45067

  • CHU Cochin

    Paris, 75014

  • Croix Saint Simon

    Paris, 75020

  • Hôpital Saint Antoine

    Paris, 75571

  • Hôpital Tenon

    Paris, 75970

  • Centre Hospitalier Paris Saint Joseph

    Paris

  • Groupe Hospitalier Pitié Salpêtrière

    Paris

  • Hôpital Saint Louis

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • HEGP

    Paris, Île-de-France Region, 75015

  • Centre Hospitalier

    Pau, 64046

  • Polyclinique Francheville

    Périgueux

  • Centre Hospitalier Saint Jean

    Perpignan

  • Hôpital Haut Leveque

    Pessac, 33604

  • CHU Lyon Sud

    Pierre-Bénite

  • Hôpital de la Milétrie

    Poitiers, 86021

  • CH Annecy Genevois

    Pringy, 74374

  • CHU Robert Debré

    Reims, 51092

  • Institut Jean Godinot

    Reims

  • Centre Hospitalier de Romans Sur Isere

    Romans-sur-Isère

  • CHU Charles Nicolle

    Rouen, 76031

  • Chi Poissy Saint Germain

    Saint-Germain-en-Laye

  • Centre Hospitalier Prive Saint Gregoire

    Saint-Grégoire

  • Clinique de L Union

    Saint-Jean

  • Polyclinique Côte Basque

    Saint-Jean-de-Luz

  • Centre Joliot Curie

    Saint-Martin-Boulogne, 62280

  • Clinique Mutualiste de L Estuaire

    Saint-Nazaire

  • CHU de Saint Etienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42270

  • Institut Lucien Neuwirth

    Saint-Priest-en-Jarez

  • Plyclinique Saint Claude

    Saint-Quentin, 02100

  • Clinique Trenel

    Sainte-Colombe, 69560

  • Clinique Charcot

    Sainte-Foy-lès-Lyon

  • Centre de cancérologie

    Sarcelles, 95200

  • CH

    Senlis, 60309

  • Centre Hospitalier de Soissons

    Soissons

  • Centre Hospitalier de Saint Malo

    St-Malo, 35403

  • Clinique de La Cote D Emeraude

    St-Malo

  • Clinique Sainte Anne

    Strasbourg, 67000

  • Centre Paul Strauss

    Strasbourg

  • Les Hopitaux Universitaires de Strasbourg

    Strasbourg

  • Hôpitaux du Leman

    Thonon-les-Bains, 74203

  • Clinique Pasteur

    Toulouse, 31300

  • Hôpital Trousseau

    Tours, 37044

  • Centre Hospitalier de Troyes

    Troyes, 10003

  • Centre Hospitalier de Troyes

    Troyes

  • entre Hospitalier

    Valenciennes, 59322

  • CHU Nancy-Brabois

    Vandœuvre-lès-Nancy, 54511

  • Hôpital Privé de Villeneuve d'Asq

    Villeneuve-d'Ascq

  • Centre Hospitalier Intercommunal

    Villeneuve-Saint-Georges

  • Medipole Hopital Mutualiste Lyon Villeurbanne

    Villeurbanne

Other trials in France

Martinique2 sites

  • CHU de Fort de France

    Fort-de-France, 97261

  • Chu Martinique

    Fort-de-France

Other trials in Martinique

About this study

Official title: ESSAI DE PHASE III RANDOMISE EVALUANT LE FOLFOX AVEC OU SANS DOCETAXEL (TFOX) EN 1ère LIGNE DE CHIMIOTHERAPIE DES ADENOCARCINOMES OESO-GASTRIQUES LOCALEMENT AVANCES OU METASTATIQUES

Gastric cancer is the fourth commonest cancer and the second largest cause of mortality from cancer. Surgical resection of localised forms of gastric cancer offers the only chance of a cure. The vast majority of patients, however, present with advanced disease from the outset (locally advanced or metastatic) or recurrent after resection of a localised form.

For metastatic or locally advanced stages of gastric or gastro-oesophageal junction adenocarcinoma, the combination of 2 chemotherapy drugs (dual therapy) as compared with monotherapy or no chemotherapy, makes it possible to improve the tumour response and patient survival. Dual therapy comprising cisplatin + fluoropyrimidine (CF protocol) is considered as one of the first-line chemotherapy treatment standards.

Read more

The addition of docetaxel to the CF regime (referred to as the DCF protocol) has made it possible to improve the tumour response rate, the time to tumour progression and overall survival in a randomised phase III trial. This improvement in treatment efficacy was achieved, however, at the expense of a significant increase in grade 3-4 toxicity, including diarrhoea , neutropenia, and neutropenia with complications. Although DCF is considered as a therapeutic standard for advanced forms of gastric cancer, its use is limited in clinical practice due to its high toxicity.

Oxaliplatin has shown its usefulness in treatment of oesophagogastric cancer, with an efficacy at least equal to that of cisplatin. Peripheral sensory neuropathy was less common in the 5FU-cisplatin arm. In terms of treatment efficacy, 5FU-oxaliplatin versus 5FU-cisplatin was associated with a non-significant improvement in median progression free survival rates, and overall survival.

All these data thus suggest that 5FU-oxaliplatin is at least as efficacious and is better tolerated than 5FU-cisplatin, and also that docetaxel-5FU-cisplatin is more efficacious than 5FU-cisplatin, with limited use due to its high toxicity. In the logical continuation of development of chemotherapy protocols for metastatic gastric cancer, the question therefore arises of the usefulness of adding docetaxel to 5FU-oxaliplatin, in terms of efficacy and also tolerance.

In France, chemotherapy with FOLFOX is used extensively as a first line of treatment in advanced gastric cancer, but with progression-free survival and median survival rates that are still too low, and a poor response rate. The use of docetaxel at a dose of 50 mg/m2 every 2 weeks in combination with FOLFOX (TFOX protocol) has shown very interesting results in phase II studies in terms of efficacy and tolerability, and these are worth confirming through a phase III randomised trial. In fact, if these results are confirmed in phase III, TFOX could become the new first-line therapeutic standard for advanced gastric cancer, while limiting toxicity and preserving patients' quality of life, and could become the reference treatment to accompany the targeted therapies currently being developed for this disease.

The primary objective of this randomised phase III trial is to compare the progression-free survival on dual therapy with 5FU-oxaliplatin (FOLFOX protocol) with triple therapy with 5FU-oxaliplatin-docetaxel (TFOX protocol) in treatment of advanced forms of gastric or oesophagogastric junction adenocarcinoma. The secondary objectives are overall survival, the tumour response rate, toxicity, quality of life and the therapeutic index, defined as the ratio between the median progression-free survival and the febrile neutropenia rate.

Being tested
Oxaliplatin, 5Fluorouracil bolus, 5Fluorouracil continu, Docetaxel, Folinic Acid
Keywords
OESOPHAGO-GASTRIC CARCINOMA

What participants receive

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

Study groups in NCT03006432
Study groupRoleWhat they receive
FOLFOXActive comparatorCycles every 15 days until progression desease
Receives: Drug: Oxaliplatin; Drug: 5Fluorouracil bolus; Drug: 5Fluorouracil continu; Drug: Folinic Acid
TFOXExperimentalCycles every 15 days until progression desease
Receives: Drug: Oxaliplatin; Drug: 5Fluorouracil continu; Drug: Docetaxel; Drug: Folinic Acid

What is being measured

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

  1. progression-free survival

    Measured: 12 months after laste randomisation

Secondary outcomes (3)

  1. Overall survival Toxicity events (adverse events) according to NCI-CTC v4.0

    Measured: 12 months after laste randomisation

  2. Objective response rate

    Measured: 12 months after laste randomisation

  3. Toxicity events according to NCI-CTC v4.0

    Measured: 12 months after laste randomisation

Timeline

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

  1. First posted30 Dec 2016 (estimated)
  2. Study start19 Dec 2016
  3. Primary completion27 Feb 2025
  4. Study completion27 Feb 2025

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
507 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03006432
Sponsor's protocol ID
PRODIGE 51
Acronym
GASTFOX
Status last verified
Jan 2025
First submitted
27 Dec 2016
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Zaanan A, Samalin E, Aparicio T, Bouche O, Laurent-Puig P, Manfredi S, Michel P, Monterymard C, Moreau M, Rougier P, Tougeron D, Taieb J, Louvet C. Phase III randomized trial comparing 5-fluorouracil and oxaliplatin with or without docetaxel in first-line advanced gastric cancer chemotherapy (GASTFOX study). Dig Liver Dis. 2018 Apr;50(4):408-410. doi: 10.1016/j.dld.2018.01.119. Epub 2018 Mar 1.

    PubMed 29409778

  • Zaanan A, Bouche O, de la Fouchardiere C, Le Malicot K, Pernot S, Louvet C, Artru P, Le Brun Ly V, Aldabbagh K, Khemissa-Akouz F, Lecomte T, Castanie H, Laly M, Botsen D, Roth G, Samalin E, Muller M, Breysacher G, Manfredi S, Phelip JM, Taieb J. TFOX versus FOLFOX in first-line treatment of patients with advanced HER2-negative gastric or gastro-oesophageal junction adenocarcinoma (PRODIGE 51- FFCD-GASTFOX): an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2025 Jun;26(6):732-744. doi: 10.1016/S1470-2045(25)00130-5. Epub 2025 Apr 23.

    PubMed 40286809

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxaliplatin, 5Fluorouracil bolus and 5Fluorouracil continu in people with OESOPHAGO-GASTRIC CARCINOMA, run by Federation Francophone de Cancerologie Digestive at 134 sites in 2 countries.

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

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in France, 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?

progression-free survival (time frame: 12 months after laste randomisation). 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 NCT03006432, 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 5 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in