Phase III randomised trial evaluating FOLFOX with or without DOCETAXEL (TFOX) as 1st line chemotherapy for locally advanced or metastatic oesophago-gastric adenocarcinoma

2024-515221-29-00 Protocol PRODIGE 51 - GASTFOX Phase II and Phase III (Integrated) Ended

Start 19 Dec 2016 · End 27 Feb 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol PRODIGE 51 - GASTFOX

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Ended
Participants planned 507
Countries 1
Sites 1

Locally advanced or metastatic oesogastric adenocarcinoma

progression-free survival 12 months after the last randomization

Key facts

Sponsor
Fondation Franc.Cancerologie Digestive
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
19 Dec 2016 → 27 Feb 2025
Decision date (initial)
2024-07-04
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Fondation Francophone de Cancérologie Digestive

External identifiers

EU CT number
2024-515221-29-00
EudraCT number
2016-002331-16
ClinicalTrials.gov
NCT03006432

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

progression-free survival 12 months after the last randomization

Secondary objectives 4

  1. Overall survival
  2. Objective response rate
  3. Toxicity events according to NCI-CTC v4.0
  4. Quality of life (EORTC QLQ-C30 + STO- 22 questionnaire)

Conditions and MedDRA coding

Locally advanced or metastatic oesogastric adenocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Histologically proven adenocarcinoma of the gastric or oesogastric junction (any Siewert) (on primary tumour or metastatic lesion)
  2. HER2 negative (HER2 positive status is defined by a positive IHC test at 3+ or IHC at 2+ with positive FISH)
  3. Metastatic or unresectable (locally advanced) disease
  4. Disease measurable according to RECIST v1.1 criteria (at least one measurable lesion)
  5. No major surgical procedure during the 4 weeks prior to randomisation
  6. Patient eligible for a 1st line of chemotherapy based on 5FU, folinic acid and oxaliplatin (FOLFOX) with or without docetaxel (TFOX)
  7. WHO: 0-1
  8. Age ≥ 18

Exclusion criteria 11

  1. Presence of cerebral or meningeal metastases
  2. Presence of > grade 2 neuropathy according to NCIC-CTC 4.0
  3. Known DPD deficiency
  4. Any known specific contraindication or allergy to the treatments used in the study
  5. Chemotherapy or radio-chemotherapy in an adjuvant situation finished less than 12 months ago
  6. Any progressive pathology not stabilised over the past 6 months: liver impairment, renal impairment, respiratory or cardiac failure
  7. HIV+ patients
  8. Prior chemotherapy including oxaliplatin (except for adjuvant chemotherapy)
  9. Prior chemotherapy including docetaxel
  10. Radiotherapy during the 4 weeks prior to randomisation
  11. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. To assess the progression free survival at 12 months after the last randomisation

Secondary endpoints 1

  1. To assess the overall survival

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Oxaliplatin

SUB09490MIG · Substance

Active substance
Oxaliplatin
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS PERFUSION USE
Max daily dose
85 mg/m2 milligram(s)/sq. meter
Max total dose
4080 mg/m2 milligram(s)/sq. meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SUB07721MIG · Substance

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS BOLUS USE
Max daily dose
400 mg/m2 milligram(s)/sq. meter
Max total dose
19200 mg/m2 milligram(s)/sq. meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SUB07721MIG · Substance

Active substance
Fluorouracil
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS PERFUSION USE
Max daily dose
2400 mg/m2 milligram(s)/sq. meter
Max total dose
115200 mg/m2 milligram(s)/sq. meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Calcium Levofolinate

SUB06054MIG · Substance

Active substance
Calcium Levofolinate
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
400 mg/m2 milligram(s)/sq. meter
Max total dose
19200 mg/m2 milligram(s)/sq. meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Anhydrous Docetaxel

SUB22289 · Substance

Active substance
Anhydrous Docetaxel
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
50 mg/m2 milligram(s)/sq. meter
Max total dose
2400 mg/m2 milligram(s)/sq. meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondation Franc.Cancerologie Digestive

19 Total trials 7 Recruiting 11 Ended
Academic / Non-commercial
Sponsor organisation
Fondation Franc.Cancerologie Digestive
Address
7 Boulevard Jeanne D Arc
City
Dijon Cedex
Postcode
21001
Country
France

Scientific contact point

Organisation
Fondation Franc.Cancerologie Digestive
Contact name
Pr Aziz ZAANAN

Public contact point

Organisation
Fondation Franc.Cancerologie Digestive
Contact name
Leathicia NDONG

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ended 507 1
Rest of world — 0 —

Investigational sites

France

1 site · Ended
Hôpital Européen George Pompidou
gastro enterology, 20 rue Leblanc, 75015, PARIS

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2016-12-19 2025-02-27

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
PRODIGE 51 - GASTFOX Study results
SUM-116422
 2026-01-26T16:16:08 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
PRODIGE 51 - GASTFOX - Lay person summary of results 2026-01-26T16:16:39 Submitted Laypersons Summary of Results

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) P51_Lay person summary of results 1
Protocol (for publication) D1_ Protocol FR GASTFOX v3 22062022 3.0
Recruitment arrangements (for publication) Document additionnel 19062023 1
Subject information and informed consent form (for publication) L1 SIS and ICF clinical v2 10112021 propre 2
Subject information and informed consent form (for publication) L1 SIS and ICF biological v2 10112021 propre 2
Summary of Product Characteristics (SmPC) (for publication) SMPC 5 FU 30112015 1
Summary of Product Characteristics (SmPC) (for publication) SMPC Eloxatine 26012016 1
Summary of Product Characteristics (SmPC) (for publication) SMPC Elvorine 07042016 1
Summary of Product Characteristics (SmPC) (for publication) SMPC Taxotere 1
Summary of results (for publication) GASTFOX_summary_of-results_CTIS 1
Synopsis of the protocol (for publication) D1_ Protocol synopsis FR GASTFOX V3 22062022 3.0

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-20 France Acceptable
2024-07-03
 2024-07-04

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