Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
130
Countries
2
Sites
82
Small bowel adenocarcinoma
Assessment of the percentage of patients alive without progression at 8 months
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Dijon
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 9 Feb 2024 → ongoing
- Decision date (initial)
- 2023-09-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- PHRC K 2022
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
Assessment of the percentage of patients alive without progression at 8 months
Secondary objectives 7
- Overall Survival
- Progression-free survival
- Time to treatment failure
- Better response during first line tratment
- Treatment tolerance
- Quality of life during treatment
- Progression-free survival in 2nd line of total population and by 2nd line treatment
Conditions and MedDRA coding
Small bowel adenocarcinoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Histologically proven adenocarcinoma of the small intestine (duodenum, jejunum, ileum)
- Metastatic or locally advanced unresectable tumour with curative intent
- Patient who never received first-line chemotherapy
- Measurable lesion according to RECIST 1.1 criteria
- ECOG status < or = 2 for patients under 70 years, or 0 or 1 for patients over 70 years
- Life expectancy estimated at over 3 months
Exclusion criteria 12
- MSI/dMMR tumor
- Adenocarcinoma of the ampulla of Vater
- Neutrophils < 1500/mm3, platelets < 100 000/mm3
- Hemoglobin < 9 g/dL, total bilirubin > 1.5x normal, alkaline phosphatase > 2.5x normal (or >5x normal if liver metastases), creatinine clearance > or = 40 ml/min. according to MDRD
- Adjuvant chemotherapy completed less than 6 months ago
- History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure
- Severe renal failure
- Peripheral sensory neuropathy with functional discomfort
- Active and/or potentially severe infection or other uncontrolled conditions
- Treatment with a cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment
- Uncontrolled inflammatory bowel disease and/or unresolved bowel obstruction
- Administration of live vaccines within 28 days prior to randomization
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression at 8 months
Secondary endpoints 2
- Survival
- Pregression-free survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Irinotecan Hydrochloride Trihydrate
SUB45873 · Substance
- Active substance
- Irinotecan Hydrochloride Trihydrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 180 mg/ml milligram(s)/millilitre
- Max total dose
- 180 mg/ml milligram(s)/millilitre
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 85 mg/m2 milligram(s)/sq. meter
- Max total dose
- 85 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06054MIG · Substance
- Active substance
- Calcium Levofolinate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 4
SUB06054MIG · Substance
- Active substance
- Calcium Levofolinate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 85 mg/ml milligram(s)/millilitre
- Max total dose
- 85 mg/ml milligram(s)/millilitre
- Max treatment duration
- 36 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
Centre Hospitalier Universitaire De Dijon
- Sponsor organisation
- Centre Hospitalier Universitaire De Dijon
- Address
- 1 Boulevard Jeanne D Arc, Bp 77908 Bp 77908
- City
- Dijon
- Postcode
- 21000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Dijon
- Contact name
- Coordinator
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Dijon
- Contact name
- Coordinator
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Fondation Franc.Cancerologie Digestive ORG-100007358
|
Dijon Cedex, France | On site monitoring, Code 10, Code 13, Code 14, Code 5, Data management, Code 8, Code 9 |
Locations
2 EU/EEA countries · 82 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 100 | 62 |
| Italy | Authorised, recruitment pending | 30 | 20 |
| Rest of world | — | 0 | — |
Investigational sites
Hopital Saint Joseph
Hepatogastroenterology, 26 Boulevard De Louvain, 13008, Marseille
Hopital Europeen Marseille
Gastroenterology, 6 Rue Desiree Clary, 13003, Marseille
Centre Hospitalier D Avignon
Gastroenterology, 305 Rue Raoul Follereau, 84000, Avignon
Centre Hospitalier Annecy Genevois
Hepatogastroenterology, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Centre Hospital Region Metz Thionville
Hepatogastroenterology, 1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Metz Cedex 03
Les Hopitaux De Chartres
Oncology, 4 Rue Claude Bernard, 28630, Le Coudray
Centre Paul Strauss
Oncology, 17 Rue Albert Calmette BP23025, STRASBOURG, STRASBOURG, Alsace
Centre Hospitalier De La Cote Basque
Oncology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
GHBS Lorient
Gastroenterology, 5 Avenue de Choiseul, France, LORIENT
Centre Hospitalier De Saint Malo
Hepatogastroenterology, 1 Rue De La Marne, 35403, Saint-Malo Cedex
Centre Hospitalier Boulogne Sur Mer
Oncology, Allée Jacques Monod, France
CHU De Rouen
Gastroenterology, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Oscar Lambret
Oncology, 3 Rue Frederic Combemale, 59000, Lille
CH Villefranche Nord Ouest
Gastroenterology, Plateau d'Ouilly-Gleize, BP 80436, VILLEFRANCHE-SUR-SAONE
Centre Hospitalier Universitaire De Caen Normandie
Hepatogastroenterology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
CHRU de Lille - Hôpital Huriez
Oncology, Rue Michel Polonowski, 59037, Lille cedex
Centre Hospitalier Universitaire De Saint Etienne
Gastroenterology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Assistance Publique Hopitaux de Paris – Hopital Cochin
Gastroenterology, 27 Rue du Faubourg Saint-Jacques, 75014, Paris
Centre Hospitalier Universitaire Reims
Gastroenterology, Rue Du General Koenig, 51092, Reims Cedex
Polyclinique Saint Côme
Oncology, 7 rue Jean Jacques Bernard, BP 70409, COMPIEGNE
Grand Hopital De L Est Francilien
Gastroenterology, 6 Rue Saint Fiacre, 77100, Meaux
Centre De Lutte Contre Le Cancer Eugene Marquis
Oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Groupe Hospitalier Nord Essonne
Oncology, ZAC De Corbeville, 1 Parvis De L Hopital, Orsay
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Polyclinique Bordeaux Nord Aquitaine
Hepatogastroenterology, 15 Rue Claude Boucher, Cs 31396, Bordeaux Cedex
Institut De Cancerologie De L Ouest
Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
University Hospital Of Clermont-Ferrand
Oncology, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Hopital Beaujon
Gastroenterology, 100 Boulevard Du General Leclerc, 92110, Clichy
Strasbourg Oncologie Libérale - Clinique Sainte-Anne
Oncology, 182 route de la Wantzenau, 67000, STRASBOURG
Centre Hospitalier De Pau
Hepatogastroenterology, 4 Boulevard Hauterive, Cs 17595, Pau Cedex
CHRU De Nancy
Oncology, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Institut Godinot
Oncology, 1 Rue Du General Koenig, 51100, Reims
Centre Hospitalier Bretagne Atlantique
Gastroenterology, 20 Boulevard General Maurice Guillaudot, 56000, Vannes
Centre Hospitalier D Auxerre
Oncology, 2 Boulevard De Verdun, 89000, Auxerre
Hopital Haut Leveque
Gastroenterology, Avenue Magellan, 33604, Pessac
Hopital Prive Jean Mermoz
Gastroenterology, 55 Avenue Jean Mermoz, 69008, Lyon
Groupe Hospitalier Nord Essonne
Oncology, 159 rue François Mitterrand, 91160, Longjumeau
Centre Hospitalier Regional Universitaire De Tours
Oncology, 2 Boulevard Tonnelle, 37000, Tours
Sainte Catherine Institut Du Cancer Avignon-Provence
Oncology, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Clinique Sainte Clotilde
Oncology, 127 Rte de Bois de Nefles, 97400, Saint-Denis , La Réunion
Centre Hospitalier Aunay-Bayeux
Gastroenterology, 13 Rue De Nesmond, 14400, Bayeux
Hospital Edouard Herriot
Oncology, 5 Place D Arsonval, 69003, Lyon
Centre Hospitalier Regional Universitaire
Oncology, 2 Place Saint Jacques, Cs 51804, Besancon Cedex
Centre Hospitalier Universitaire Amiens Picardie
Hepatogastroenterology, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Departemental Vendee
Gastroenterology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier D Albi
Oncology, 22 Boulevard General Sibille, 81000, Albi
Assistance Publique Hopitaux De Marseille
Hepatogastroenterology, 264 Rue Saint Pierre, 13005, Marseille
Assistance Publique Hopitaux De Paris
Hepatogastroenterology, Porte 23, 1 Avenue Claude Vellefaux, Paris Cedex 10
Centre Hospitalier Universitaire De Poitiers
Gastroenterology, 2 Rue De La Miletrie, 86000, Poitiers
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
Oncology, 8 Rue Docteur Calmette, 38000, Grenoble
Centre Hospitalier Lyon Sud
Gastroenterology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Hopital De La Croix Rousse
Gastroenterology, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Azuréen de Cancérologie
Oncology, 1 Place du Dr Jean-Luc Broquerie, 06250, MOUGINS
Hopital NOVO
Oncology, 6 Avenue De L Ile De France, 95300, Pontoise
Centre Hospitalier Universitaire De Rennes
Oncology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Dijon
Hepatogastroenterology, 1 Boulevard Jeanne D Arc, Bp 77908, Dijon
Centre Hospitalier De Cholet
Oncology, 1 Rue De Marengo, 49300, Cholet
Centre Hospitalier De Saint-Denis
Oncology, 2 Rue Du Docteur Delafontaine, 93200, Saint-Denis
Centre Hospitalier De Flers
Hepatogastroenterology, Rue eugène garnier, 60219
Médipôle Hôpital Mutualiste Lyon-Villeurbanne
Gastroenterology, 158 rue Leon Blum, 69100, VILLEURBANNE
Centre Hospitalier Universitaire Grenoble Alpes
Hepatogastroenterology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Clinique Belharra
Oncology, 2 Allée du Dr Robert Lafon, 64100, Bayonne
Azienda USL IRCCS Di Reggio Emilia
Oncology, Viale Risorgimento 80, 42123, Reggio Emilia
Ospedale San Raffaele S.r.l.
Oncology, Via Olgettina 60, 20132, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncology, Largo Francesco Vito 1, 00168, Rome
Centro Di Riferimento Oncologico Di Aviano
Oncology, Via Franco Gallini 2, 33081, Aviano
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncology, Via Piero Maroncelli 40, 47014, Meldola
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Oncology, Via Sergio Pansini 5, 80131, Naples
Pia Fondazione Di Culto E Religione Card G Panico
Oncology, Via Pio X 4, 73039, Tricase
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncology, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliero Universitaria Careggi
Oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Oncology, Viale Oxford 81, 00133, Rome
Azienda USL Toscana Centro
Oncology, Via Suor Niccolina Infermiera 20/22, 59100, Prato
Azienda Unita Sanitaria Locale Della Romagna
Oncology, Viale Vincenzo Randi 5, 48121, Ravenna
Istituto Tumori Bari Giovanni Paolo II
Oncology, Viale Orazio Flacco 65, 70124, Bari
IRCCS Humanitas Research Hospital
Oncology, Via Manzoni, 56, Rozzano
Azienda Ospedaliero Universitaria Pisana
Oncology, Via Roma 67, 56126, Pisa
Azienda Ospedaliero Universitaria Di Modena
Oncology, Via Pietro Giardini 1355, 41126, Modena
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Oncology, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Sanitaria Universitaria Friuli Centrale
Oncology, Via Pozzuolo 330, 33100, Udine
Istituto Oncologico Veneto
Oncology, Via Gattamelata 64, 35128, Padova
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-02-09 | 2024-02-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 35 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 202350548692 FOLFIRINOX SBA CLEAN | 2.0 |
| Protocol (for publication) | D1_Protocol 202350548692 FOLFIRINOX SBA V2 TC | 2.0 |
| Protocol (for publication) | SM4 Summary of changes 2023-505214-23-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EORTC QLQ-C30 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EORTC QLQ-C30_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Questionnaire | 3 |
| Subject information and informed consent form (for publication) | SIS AND ICF FOLFIRINOX SBA | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CALCIO LEVOFOLINATO TEVA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CALCIO LEVOFOLINATO TEVA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FLUOROURACIL TEVA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FLUOROURACIL TEVA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FLUOROURACIL TEVA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IRINOTECAN MYLAN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC OXALIPLATINO ACCORD | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC OXALIPLATINO ACCORD | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC ELVORINE | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC ELVORINE | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC FLUOROURACILE PFIZER | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC FLUOROURACILE PFIZER | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC FLUOROURACILE PFIZER | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC IRINOTECAN MEDAC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC OXALIPLATINE TEVA | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC OXALIPLATINE TEVA | 2.0 |
| Synopsis of the protocol (for publication) | D1_SINOSSI 202350548692 clean | 2.0 |
| Synopsis of the protocol (for publication) | D1_SINOSSI 202350548692 tc | 2.0 |
| Synopsis of the protocol (for publication) | D1_SYNOPSIS 202350548692 clean | 2.0 |
| Synopsis of the protocol (for publication) | D1_SYNOPSIS 202350548692 clean | 2.1 |
| Synopsis of the protocol (for publication) | D1_Synopsis 202350548692 TC | 2.0 |
| Synopsis of the protocol (for publication) | D1_Synopsis 202350548692 tc | 2.1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-15 | France | Acceptable 2023-08-28
|
2023-09-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-04 | France | Acceptable | 2024-10-25 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-10-09 | 2025-11-27 | ||
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-12 | France | Acceptable 2026-05-12
|
2026-05-12 |