PHASE III RANDOMISED TRIAL to EVALUATE FOLFOX with or WITHOUT DOCETAXEL (TFOX) AS 1st LINE CHEMOTHERAPY for LOCALLY ADVANCED or METASTATIC OESOPHAGO-GASTRIC CARCINOMA
NCT ID: NCT03006432
Last Updated: 2025-03-05
Study Results
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Basic Information
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COMPLETED
PHASE3
507 participants
INTERVENTIONAL
2016-12-19
2025-02-27
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FOLFOX
Cycles every 15 days until progression desease
Oxaliplatin
5Fluorouracil bolus
5Fluorouracil continu
Folinic Acid
TFOX
Cycles every 15 days until progression desease
Oxaliplatin
5Fluorouracil continu
Docetaxel
Folinic Acid
Interventions
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Oxaliplatin
5Fluorouracil bolus
5Fluorouracil continu
Docetaxel
Folinic Acid
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
Exclusion Criteria
* 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)
* 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
18 Years
ALL
No
Sponsors
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UNICANCER
OTHER
GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Aziz ZAANAN
Role: STUDY_CHAIR
HEGP, Paris
Locations
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CH d'Abbeville
Abbeville, , France
CHU Amiens-Picardie
Amiens, , France
CHU d'Angers
Angers, , France
Hôpital Privé D'Antony
Antony, , France
Centre Hospitalier Victor Dupouy
Argenteuil, , France
CH d'Auxerre
Auxerre, , France
CH de la Côte Basque
Bayonne, , France
CH
Beauvais, , France
Centre de Radiothérapie Pierre Curie
Beuvry, , France
CH Germont et Gauthier
Béthune, , France
Centre Hospitalier Germon Et Gauthier
Béthune, , France
CH de Blois
Blois, , France
Clinique Tivoli
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Polyclinique de Bordeaux Nord
Bordeaux, , France
Polyclinique Saint Privat
Boujan-sur-Libron, , France
CMCO Côte d'Opale
Boulogne-sur-Mer, , France
Hôpital Duchenne
Boulogne-sur-Mer, , France
Centre Hospitalier Fleyriat
Bourg-en-Bresse, , France
Hôpital Pierre Oudot
Bourgoin, , France
Centre Hospitalier Pierre Oudot
Bourgoin, , France
CHU Côte de Nacre
Caen, , France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, , France
Médipôle de Savoie
Challes-les-Eaux, , France
CH William Morey
Chalon-sur-Saône, , France
Centre Hospitalier William Morey
Chalon-sur-Saône, , France
CH Metropole Savoie
Chambéry, , France
Hopital Prive Paul D Engine
Champigny-sur-Marne, , France
Hopitaux de Chartres, Centre Hospitalier Louis Pasteur
Chartres, , France
Centre Hospitalier Général
Châlons-en-Champagne, , France
Centre Hospitalier de Cholet
Cholet, , France
Hopital D Instruction Des Armées Percy
Clamart, , France
Hopitaux civils de Colmar
Colmar, , France
Clinique Saint Côme
Compiègne, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
Clinique des Cèdres
Cornebarrieu, , France
Groupe Hospitalier Du Sud de L'Oise
Creil, , France
Hôpital Henri Mondor
Créteil, , France
CHI
Créteil, , France
Institut de Cancérologie de Bourgogne - GRRECC
Dijon, , France
Centre Georges-François Leclerc
Dijon, , France
CHU
Dijon, , France
Centre Hospitalier de Dinan
Dinan, , France
CHI Elbeuf-Louvier-Val de Reuil
Elbeuf, , France
Centre Hospitalier Intercommunal Elbeuf-Louviers/Val de Reuil
Elbeuf, , France
Hôpital Jacques Monod
Flers, , France
CHI de Fréjus Saint-Raphaël
Fréjus, , France
GHM Institut Daniel Hollard
Grenoble, , France
Chu Albert Michallon
Grenoble, , France
Hôpital privé Toulon/Hyères
Hyères, , France
CHD Vendée
La Roche-sur-Yon, , France
CHU Grenoble - Hôpital Albert Michallon
La Tronche, , France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, , France
Institut Hospitalier Franco-Britannique
Levallois-Perret, , France
Chu Claude Huriez
Lille, , France
Clinique François Chénieux
Limoges, , France
CHU Dupuytren
Limoges, , France
CH Longjumeau
Longjumeau, , France
Clinique de la Sauvegarde
Lyon, , France
CHU de Lyon - Croix Rousse
Lyon, , France
CH Saint Joseph - Saint Luc
Lyon, , France
Centre Léon Berard
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Hopital Saint Joseph -Saint Luc
Lyon, , France
Hôpital Privé Jean Mermoz
Lyon, , France
Centre Hospitalier Francois Quesnay
Mantes-la-Jolie, , France
CHU La Timone
Marseille, , France
Hôpital Nord
Marseille, , France
Association Hopital Saint Joseph de Marseille
Marseille, , France
Hôpital Européen
Marseille, , France
CH
Meaux, , France
Hopital Marc Jacquet
Melun, , France
Centre Hospitalier
Montélimar, , France
Ghi Le Raincy-Montfermeil
Montfermeil, , France
Hôpital Monod
Montivilliers, , France
Institut Régional du Cancer Montpellier
Montpellier, , France
Chu de Nancy
Nancy, , France
Hôpital privé du Confluent SAS
Nantes, , France
Chu de Nantes
Nantes, , France
CH Pierre Bérégovoy
Nevers, , France
CH de Niort
Niort, , France
CH Régional de la Source
Orléans, , France
Hôpital de la source
Orléans, , France
CHU Cochin
Paris, , France
Croix Saint Simon
Paris, , France
Hôpital Saint Antoine
Paris, , France
Hôpital Tenon
Paris, , France
Centre Hospitalier Paris Saint Joseph
Paris, , France
Groupe Hospitalier Pitié Salpêtrière
Paris, , France
Hôpital Saint Louis
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Centre Hospitalier
Pau, , France
Centre Hospitalier Saint Jean
Perpignan, , France
Hôpital Haut Leveque
Pessac, , France
Polyclinique Francheville
Périgueux, , France
CHU Lyon Sud
Pierre-Bénite, , France
Hôpital de la Milétrie
Poitiers, , France
CH Annecy Genevois
Pringy, , France
CHU Robert Debré
Reims, , France
Institut Jean Godinot
Reims, , France
Centre Hospitalier de Romans Sur Isere
Romans-sur-Isère, , France
CHU Charles Nicolle
Rouen, , France
Chi Poissy Saint Germain
Saint-Germain-en-Laye, , France
Centre Hospitalier Prive Saint Gregoire
Saint-Grégoire, , France
Clinique de L Union
Saint-Jean, , France
Polyclinique Côte Basque
Saint-Jean-de-Luz, , France
Centre Joliot Curie
Saint-Martin-Boulogne, , France
Clinique Mutualiste de L Estuaire
Saint-Nazaire, , France
CHU de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, , France
Institut Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Plyclinique Saint Claude
Saint-Quentin, , France
Clinique Trenel
Sainte-Colombe, , France
Clinique Charcot
Sainte-Foy-lès-Lyon, , France
Centre de cancérologie
Sarcelles, , France
CH
Senlis, , France
Centre Hospitalier de Soissons
Soissons, , France
Centre Hospitalier de Saint Malo
St-Malo, , France
Clinique de La Cote D Emeraude
St-Malo, , France
Clinique Sainte Anne
Strasbourg, , France
Centre Paul Strauss
Strasbourg, , France
Les Hopitaux Universitaires de Strasbourg
Strasbourg, , France
Hôpitaux du Leman
Thonon-les-Bains, , France
Clinique Pasteur
Toulouse, , France
Hôpital Trousseau
Tours, , France
Centre Hospitalier de Troyes
Troyes, , France
Centre Hospitalier de Troyes
Troyes, , France
entre Hospitalier
Valenciennes, , France
CHU Nancy-Brabois
Vandœuvre-lès-Nancy, , France
Hôpital Privé de Villeneuve d'Asq
Villeneuve-d'Ascq, , France
Centre Hospitalier Intercommunal
Villeneuve-Saint-Georges, , France
Medipole Hopital Mutualiste Lyon Villeurbanne
Villeurbanne, , France
HEGP
Paris, Île-de-France Region, France
CHU de Fort de France
Fort-de-France, , Martinique
Chu Martinique
Fort-de-France, , Martinique
Countries
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References
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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.
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.
Other Identifiers
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PRODIGE 51
Identifier Type: -
Identifier Source: org_study_id
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