PRODIGE 85 (FFCD 1804) – KANALRAD Prospective randomized phase III study evaluating induction chemotherapy (modified DCF 4 cycles) followed by chemoradiotherapy compared to standard chemoradiotherapy for locally advanced anal squamous cell carcinoma (T3-4 or N1a, b or c)

2023-505972-32-00 Protocol PRODIGE85-KANALRAD Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 26 Feb 2024 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 117 sites · Protocol PRODIGE85-KANALRAD

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 310
Countries 1
Sites 117

locally advanced anal squamous cell carcinoma

Efficacy of induction chemotherapy by mDCF (4 cycles) followed by standard CRT versus standard CRT alone by comparing disease related event-free survival at 2 years.

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] - Digestive System Diseases [C06]
Trial duration
26 Feb 2024 → ongoing
Decision date (initial)
2024-01-15
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
ARCAD

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Efficacy of induction chemotherapy by mDCF (4 cycles) followed by standard CRT versus standard CRT alone by comparing disease related event-free survival at 2 years.

Secondary objectives 10

  1. Overall survival at 2 and 3 years
  2. Respect rate of dose constraints (radiotherapy quality control)
  3. Acute toxicity of treatment in 2 arms
  4. Late toxicity of treatment in 2 arms up to 3 years after the end of treatment
  5. Complete response rate at 6 months after the end of CRT
  6. Pelvic recurrence rate at 2 years
  7. Metastatic recurrence rate at 2 years
  8. Colostomy-free survival at 2 and 3 years
  9. Quality of Life (EORTC QLQ-C30 + EORTC QLQ-ANL27 + Jorge & Wexner Score) and Assessment of Sexual health (EORTC SHQ-22)
  10. Disease-free survival at 3 years

Conditions and MedDRA coding

locally advanced anal squamous cell carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Anal Squamous cell carcinoma histologically proven
  2. Locally advanced tumors without metastases (Stage T3 or T4 / Stage N1 (a, b or c) - any T (T1 to T4) )
  3. Age ≥18 and ≤ 75 or > 75 in case of favourable oncodage G8 score or oncogeriatric assessment
  4. Measurable tumor on MRI
  5. Able to receive chemotherapy and radiotherapy
  6. No major comorbidity that may preclude the delivery of treatment
  7. WHO performance status < 2

Exclusion criteria 7

  1. Presence of metastases
  2. Stage T1N0 or T2N0
  3. History of pelvic radiotherapy
  4. Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
  5. Positive HIV serology with CD4 < 400 / mm3
  6. Presence of neuropathy > grade 2
  7. Concomitant treatment with CYP3A4 inhibitors or inducers

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Disease-related event free survival (DFS) will be defined as the time between the date of randomization and the date of the first event (residual tumor at 6 months requiring an APR, progression, recurrence (local or metastatic) or death) or date of last news if the patient is alive without any event.

Secondary endpoints 7

  1. Overall survival (OS)
  2. Colostomy-free survival (CFS)
  3. toxicities and grades according to International Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
  4. Response rate will be evaluated by mRECIST criteria 1.1 and clinical examination
  5. Quality of life scores
  6. Pelvic reccurence rate at 2 years
  7. Metastatic reccurence rate at 2 years

Investigational products

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

Test 3

Cisplatin

SUB07483MIG · Substance

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS INJECTION
Max daily dose
40 mg/m2 milligram(s)/square meter
Max total dose
40 mg/m2 milligram(s)/square meter
Max treatment duration
6 Week(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/INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
1200 mg/m2 milligram(s)/square meter
Max total dose
1200 mg/m2 milligram(s)/square meter
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Docetaxel

SUB12492MIG · Substance

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

Comparator 3

Capecitabine

SUB12474MIG · Substance

Active substance
Capecitabine
Pharmaceutical form
FILM COATED TABLET
Route of administration
ORAL
Max daily dose
1650 mg/m2 milligram(s)/sq. meter
Max total dose
1650 mg/m2 milligram(s)/sq. meter
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Capecitabine

SUB12474MIG · Substance

Active substance
Capecitabine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1650 mg/m2 milligram(s)/sq. meter
Max total dose
1650 mg/m2 milligram(s)/sq. meter
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Mitomycin

SUB09006MIG · Substance

Active substance
Mitomycin
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
10 mg/m2 milligram(s)/sq. meter
Max total dose
10 mg/m2 milligram(s)/sq. meter
Max treatment duration
29 Day(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
21079
Country
France

Scientific contact point

Organisation
Fondation Franc.Cancerologie Digestive
Contact name
Véronique Vendrely

Public contact point

Organisation
Fondation Franc.Cancerologie Digestive
Contact name
Véronique Vendrely

Locations

1 EU/EEA country · 117 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruitment ended 310 117
Rest of world — 0 —

Investigational sites

France

117 sites · Ongoing, recruitment ended
Hopital NOVO
oncology, 6 Avenue De L Ile De France, 95300, Pontoise
Hôpital Privé de la Baie
radiotherapy, 1 Av. du Quesnoy, 50300, Avranches
Reseau De Sante Mutualiste
oncology, 158 Rue Leon Blum, 69100, Villeurbanne
Institut Godinot
gastroenterology, 1 Rue Du General Koenig, 51100, Reims
Centre Hospitalier Regional D'Orleans
oncology and radiotherapy, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier Victor Dupouy
oncology, 69 Rue Du Lieutenant Colonel Prudhon, 95107, Argenteuil Cedex
Centre Médico-Chirurgical Tronquières AURILLAC
Radiotherapy unit, 83 Avenue Charles de Gaulle, 15000, aurillac
Hôpital Privé Arras Les Bonnettes
oncology, 2 rue du Dr Forgeois, 62000, ARRAS
Centre Jean Perrin
Radiation oncology, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1
Centre Oscar Lambret
oncology, 3 Rue Frederic Combemale, 59000, Lille
Groupe Hospitalier Bretagne Sud
Oncology, 5 Avenue Etienne Francois De Choiseul, 56100, Lorient
Centre Hospitalier Et Universitaire De Limoges
oncologie, 2 Avenue Martin Luther King, 87000, Limoges
Centre Antoine Lacassagne
oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Hopital nord franche comté
oncology, 54 Rue du Maréchal Juin, 25200, Montbéliard
Centr Georges Francois Leclerc
Radiotherapy, 1 Rue Professeur Marion, 21000, Dijon
Clinique Ambroise Pare
Oncology-radiotherapy, Rue Delbecque, 62660, Beuvry
Centre Hospitalier De Niort
oncology, 40 Avenue Charles De Gaulle, 79000, Niort
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
Oncologist, 8 Rue Docteur Calmette, 38000, Grenoble
Hopital Prive Drome Ardeche - Clinique Generale
gastroenterology, 15 RUE JACQUES DELPEUCH, 26000, VALENCE
Hopital Prive Jean Mermoz
gastroenterology, 55 Avenue Jean Mermoz, 69008, Lyon
Centre Hospitalier Universitaire De Poitiers
HGE and oncology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Sud Francilien
oncology, 40 Avenue Serge Dassault, 91100, Corbeil Essonnes
Centre Hospitalier Tarbes-Lourdes
gastroenterology, Bd Du Mal De Lattre De Tassigny, Bp 1330, Tarbes Cedex 9
Hopital Prive De L'Estuaire
oncology, 505 Rue Irene Joliot Curie, 76620, Le Havre
Centre Hospitalier Universitaire De Bordeaux
radiothérapie, Avenue De Magellan, 33600, Pessac
Assistance Publique Hopitaux De Marseille
oncologie, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Simone Veil De Beauvais
Radiotherapy and oncology, 40 Avenue Leon Blum, 60021, Beauvais
Centre De Lutte Contre Le Cancer Eugene Marquis
radiotherapy, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Hôpitaux du Léman
Oncology, 3 avenue de la Dame, 74200, Thonon Les Bains
Institut De Cancerologie De Lorraine
radiation oncology, 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
Hopitaux Drome Nord
oncology, 607 Avenue Genev De Gaulle Anthonioz, 26100, Romans-Sur-Isere
CHU de La Réunion sites Sud
oncology, Avenue François Mitterrand BP 350 97448 Saint-Pierre Cedex, France
Clinique Belharra
oncology, 2 Allée du Dr Robert Lafon, 64100, Bayonne
Centre de radiotherapie Savoie Nord
Radiation oncology, 20 route de findrol, 74130, Contamine sur Avre
Centre Francois Baclesse
Radiotherapy, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre de Radiothérapie - Clinique Sainte Anne
oncology, 184 Route de la Wantzenau, 67000, STRASBOURG
Institut Paoli-Calmettes
Radiology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Aurillac
oncology, 50 avenue de la république, 15000, AURILLAC
Francheville perigord sante
Radiotherapy and oncology, 4 Place Francheville, 24000, Périgueux
Centre Hospitalier Departemental Vendee
gastroenterology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Hôpital Européen George Pompidou
oncology, 20 rue Leblanc, 75015, PARIS
Institut Regional Du Cancer De Montpellier
radiation onclogy, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Clinique Sainte Clotilde
Oncology, 127 Rte de Bois de Nefles, 97400, Saint-Denis , La Réunion
Centre Medico Chirurgical Ambroise Pare Hartmann
oncology, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier De Saint-Quentin
Hepato-Gastro-Entérology, 1 Rue Michel De L Hospital, 02100, Saint Quentin
Ass Hospitaliere Protestante De Lyon
gastroenterology, 3 Chemin Du Penthod, 69300, Caluire Et Cuire
Groupe de Radiothérapie et d'Oncologie des Pyrénées
radiotherapy, 57 Rue Aristide Briand 35, 64000, Pau
Centre Hospitalier D Auxerre
oncology, 2 Boulevard De Verdun, 89000, Auxerre
Centre Hospitalier Annecy Genevois
gastroenterology, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Centre Hospitalier Universitaire Reims
Ambulatory Medicine-Cancerology, 45 Rue Cognacq Jay, 51100, Reims
Centre Hospitalier Regional Universitaire
oncology, 2 Place Saint Jacques, Cs 51804, Besancon Cedex
Groupe Hospitalier Diaconesses Croix Saint Simon
oncology, 125 Rue D Avron, 75020, Paris
Hôpital Privé Nord Parisien
radiotherapy, 4 Avenue Charles Péguy, 95200, Sarcelles
Centre Hospitalier Universitaire De Rennes
oncology, 2 Rue Henri Le Guilloux, 35000, Rennes
Clinique Esquirol Saint Hilaire et Calabet
Radiotherapy unit, 13 Quai du Dr Calabet, 47000, Agen
Sainte Catherine Institut Du Cancer Avignon-Provence
oncology, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Centre Jean Perrin
digestive oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
Centre Hospitalier Jean Rougier
rheumatology, 52 Place Antonin Bergon, Bp 50269, Cahors
Centre de Radiothérapuie-oncologie de Moyenne Garonne
oncology, 13 Quai du Dr et Madame Calabet, 47000, AGEN
Hopital Tenon
Oncology-radiotherapy, 4 Rue De La Chine, 75970, Paris Cedex 20
Centre Frédéric Joliot
Radiotherapy, 7 rue de l'abreuvoir, 76000, ROUEN
Institut Curie
oncology, 26 Rue D Ulm, 75005, Paris
Hopital Prive D Antony
oncology, 1 Rue Velpeau, 92160, Antony
Centre Azuréen de Cancérologie
oncology, 1 Place du Dr Jean-Luc Broquerie, 06250, MOUGINS
Centre Hospitalier Regional Universitaire De Tours
oncology, 2 Boulevard Tonnelle, 37000, Tours
CHP Sainte Marie Osny
Radiotherapy, 1 Rue Christian Barnard, 95520, Osny
Polyclinique du Parc
oncology, 20 avenue du Capitaine Georges Guynemer, 14000, Caen
Institut De Cancerologie De Bourgogne
oncology, 18 Cours General De Gaulle, 21000, Dijon
Hopital Prive La Louviere
Oncology, 69 Rue De La Louviere, 59800, Lille
Clinique Pasteur
oncology, 45 Avenue De Lombez, Cs 27617, Toulouse Cedex 3
Polyclinique de l'Ormeau
Radiotherapy, 10 Chemin Ormeau, 65000, TARBES
Centre D'Oncologie Et De Radiotherapie 37
oncology, 11 Avenue Du Professeur Alexandre Minkowski, 37170, Chambray-Les-Tours
Centre Leon Berard
oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
radiation oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
oncology, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
Clinique Mutualiste De L'estuaire
Radiotherapy, 11 Boulevard Georges Charpak, CS 20252, SAINT NAZAIRE
Centre Hospitalier Saint Joseph Saint Luc
gastroenterology, 20 Quai Claude Bernard, 69007, Lyon
Centre Hospitalier De Dax Cote D'Argent
Radiotherapy, Boulevard Yves Du Manoir, 40100, Dax
Institut Bergonie
oncology, 229 Cours De L Argonne, 33000, Bordeaux
Clinique de la Côte d'Emeraude
Radiation oncology, 1 rue de la Maison Neuve, 35400, Saint-Malo
Centre Hospitalier Jacques PUEL
Radiotherapy, Avenue de l'Hôpital, 12000, RODEZ
Clinique Mathilde
Oncology, 7 Boulevard De L Europe, 76100, Rouen
Centre hospitalier de Saint-Denis
oncology, 2, rue du Docteur Delafontaine, Saint-Denis
Polyclinique De Limoges
oncology, 18 Rue Du General Catroux, 87039, Limoges Cedex I
Centre Hospitalier Universitaire De Saint Etienne
Radiotherapy, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Centre de Radiothérapie Marie Curie
Oncology, 159 Bd Maréchal Juin, 26000, Valence
Centre De Radiotherapie Guillaume Le Conquerant
Radiotherapy, 61 Rue Denfert Rochereau, 76600, Le Havre
HIA Sainte Anne
gastroenterology, 2 Boulevard Sainte Anne, Bp 600, Toulon Cedex 9
Centre Hospitalier Metropole Savoie
gastroenterology, Place Lucien Biset, Bp 31125, Chambery
Institut Universitaire Du Cancer Toulouse-Oncopole
radiotherapy, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Croix-Rouge Française Centre De Radiothérapie Saint Louis
Radiotherapy unit, Rue Nicolas Appert, 83100, Toulon
Reseau De Sante Mutualiste
gastroenterology and digestive cancer, 158 Rue Leon Blum, 69100, Villeurbanne
Centre Hospitalier Bethune Beuvry
Radiotherapy, 27 Rue Delbecque, 62660, Beuvry
Clinique De Flandre
oncology, 300 Rue Des Forts, 59210, Coudekerque Branche
Hopital Prive Des Cotes D'armor
oncology, 10 Rue Francois Jacob, 22190, Plerin
Centre Hospitalier Universitaire De Dijon
Hépato-Gastro-Entérologie et Oncologie, 14 Rue Paul Gaffarel, 21000, Dijon
CHU Henri Mondor
Radiotherapy, 1 Rue Gustave Eiffel, Maladies Infectieuses & U2TI, Creteil
Centre Hospitalier Universitaire De Toulouse
Oncology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Emile Muller de Mulhouse
gastroenterology, 20 Rue du Docteur Laennec - BP 1370, 68070, MULHOUSE
Centre Hospitalier Le Mans
oncology, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Valence
oncology, 179 Boulevard Marechal Juin, 26000, Valence
Hopital Saint Louis
radiotherapy, 1 Avenue Claude Vellefaux, 75010, Paris
Institut De Cancerologie Strasbourg Europe
oncology, 17 Rue Albert Calmette, 67200, Strasbourg
Centre Hospitalier De Saint Malo
gastroenterology, 1 Rue De La Marne, 35403, Saint-Malo Cedex
Clinique De l'Europe
Oncologist, 5 Allee Des Pays Bas, 80090, Amiens
Hopital Saint Joseph
oncology, 26 Boulevard De Louvain, 13008, Marseille
Clinique Tivoli Ducos
Oncologie-Radiothérapie, 220 Rue Mandron, 33000, Bordeaux
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
gastroenterology, Avenue Des Tamaris, 13100, Aix En Provence
Clinique Pasteur Lanroze
oncology, 32 Rue Auguste Kervern, 29200, Brest
Centre Marie Curie ARRAS
oncology, 1 Place de la Préfecture, 62000, ARRAS
Institut De Cancerologie De L Ouest
Radiotherapy, Bd Du Professeur Jacques Monod, 44800, St Herblain
Hopital Prive Sainte Marie Chalon
oncologie, 4 Allee De Saint Jean Des Vignes, 71100, Chalon Sur Saone
Centre Hospitalier Universitaire De Nimes
Radiotherapy and oncology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
L'Hopital Prive Du Confluent
Oncology, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2
Centre Hospitalier De Boulogne Sur Mer
digestive oncology, 12 Allee Jacques Monod, 62200, Boulogne-Sur-Mer
Institut Andree Dutreix
Radiation Oncologist, 891 Avenue De Rosendael, 59240, Dunkirk
Centre Regional Lutte Contre Le Cancer
Medical Oncology, Batiment Icans, 17 Rue Albert Calmette, Strasbourg

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 2024-02-26 2024-03-14 2026-05-26

Results and documents

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

Documents 18 files

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

TypeTitleVersion
Protocol (for publication) Modifications description 2023-505972-32-00 1
Protocol (for publication) PROTOCOL EN 20235059723200public 2
Recruitment arrangements (for publication) Recruitement arrangements v1 1
Recruitment arrangements (for publication) Site list 4
Recruitment arrangements (for publication) Site list v4_tc 4
Subject information and informed consent form (for publication) D4_Diary 1
Subject information and informed consent form (for publication) D4_QUESTIONNAIRE_ANL27 1
Subject information and informed consent form (for publication) D4_QUESTIONNAIRE_QLQ_C30 1
Subject information and informed consent form (for publication) D4_QUESTIONNAIRE_SH22 French 1
Subject information and informed consent form (for publication) SIS and ICF 2
Subject information and informed consent form (for publication) SIS and ICF_tc 2
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC 5FU Pfizer 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC Capecitabine_Xeloda 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC cisplatine VIATRIS 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC MITOMYCINE SUBSTIPHARM 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC taxotere 1
Synopsis of the protocol (for publication) PROTOCOL SYNOPSIS FR 20235059723200 2
Synopsis of the protocol (for publication) PROTOCOL SYNOPSIS FR 20235059723200_tc 2

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-09-29 France Acceptable
2024-01-08
 2024-01-15
2 SUBSTANTIAL MODIFICATION SM-1 2024-05-03 France Acceptable 2024-06-21
3 SUBSTANTIAL MODIFICATION SM-2 2025-02-06 France Acceptable
2025-04-18
 2025-04-23
4 SUBSTANTIAL MODIFICATION SM-3 2025-12-18 France Acceptable 2026-01-23

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