Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
37
Countries
4
Sites
101
colorectal cancer
Progression-free survival of under 5-fluorouracil plus Panitumumab and Sotorasib (KRAS G12C inhibitor) at 8 months in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated colorectal adenocarcinoma.
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
- 29 Aug 2025 → ongoing
- Decision date (initial)
- 2025-03-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Progression-free survival of under 5-fluorouracil plus Panitumumab and Sotorasib (KRAS G12C inhibitor) at 8 months in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated colorectal adenocarcinoma.
Secondary objectives 9
- Median progression-free survival (PFS)
- Disease control rate (DCR)
- Time to progression (TTP)
- Overall survival (OS)
- Best objective response rate (ORR)
- Duration of response (DoR)
- Safety profile
- Quality of life (QoL) and FACIT-GP5 questionnaires
- Geriatric assessment (G8 and « Geriatric COre Data sEt » (G-CODE))
Conditions and MedDRA coding
colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 13
- Age ≥ 18 years
- Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma
- Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).
- Patient unfit for doublet/triplet regimen: Frail patients (WHO PS=2),patient between 70 and 75 years old with WHO PS 1 - 2, patient ≥ 75 years old with WHO PS 0-2
- Proven KRAS G12C mutation as locally assessed by means of a IVDR compliant test.
- Measurable lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1).
- No prior treatment for the metastatic disease. Prior adjuvant chemotherapy is allowed.
- Adequate organ function: Hemoglobin > 9 g/dl, Absolute neutrophil count > 1500 /mm3, Platelets > 80 000/mm3, Creatinine clearance rate ≥50 mL/min as calculated using MDRD formula, ALT/AST ≤5×ULN and total bilirubin ≤1.5×ULN.
- Ability to understand and sign written informed consent to participate in the study.
- Provides written informed consent for the study.
- Life expectancy >6 months
- Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments
- Patient affiliated to a social security scheme for France, or equivalent for other countries
Exclusion criteria 14
- Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume <50%) severe insufficiency
- Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments)
- Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng/mL)
- Immunotherapy within 3 months before the beginning of the treatment study
- Patient under treatment by strong CYP3A4 inducers
- Other malignancy within 2 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated
- Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half-lives (whichever longer) before study entry
- Hypersensitivity to one of the active substances or to one of the excipients of the trial treatments
- Patient with interstitial lung disease or pulmonary fibrosis
- Has a known psychiatric or substance abuse disorder that would interfere with the patient’s ability to cooperate with the requirements of the study
- Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent
- Pregnant or breastfeeding woman
- Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The rate of patients alive without progression 8 months after the inclusion.
Secondary endpoints 10
- PFS will be defined as the time between date of inclusion and the date of the first radiological progression using RECIST v1.1 criteria and according to the investigator assessment or death
- DCR will be defined at each time-point as complete (CR), partial (PR), stability (S), progression (P) or not evaluable with imageries and according to the investigator
- ORR will be evaluated throughout the treatment by the imageries and according to RECIST v1.1 criteria.
- BOR will be evaluated throughout the treatment by the imageries and according to RECIST v1.1 criteria
- DoR is defined as the time between the first response of the patient and the date of radiological progression or death
- TTP will be defined as the time between the date of inclusion and the date of the first radiological progression. The death linked to the cancer’s evolution will also be considered as an event
- OS is defined by the time between the date of inclusion and the date of death (regardless of the cause)
- Quality of life will be assessed with the EORTC QLQC30 questionnaire at each evaluation. The questionnaires are completed before the first treatment and during the study
- Geriatric assessments will be performed at baseline and during treatment using the G-CODE and G8-SCORE
- Toxicity, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be recorded until 30 days after the last administration of treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 11
FOLINATE DE CALCIUM HIKMA 10 mg/mL, solution injectable/pour perfusion
PRD6613032 · Product
- Active substance
- Folinic Acid
- Substance synonyms
- LEUCOVORIN
- Pharmaceutical form
- SOLUTION FOR INJECTION/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
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- 34009 550 587 6 2
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB197397 · Substance
- Active substance
- Sotorasib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 960 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vectibix 20 mg/ml concentrate for solution for infusion
PRD526654 · Product
- Active substance
- Panitumumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 6 mg/kg milligram(s)/kilogram
- Max total dose
- 6 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FE02 — -
- Marketing authorisation
- EU/1/07/423/003
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracilo Accord 50 mg/ml solución inyectable o para perfusión EFG
PRD1972850 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/square meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 71.868
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracile AHCL 50 mg/ml, Soluzione per iniezione o infusione
PRD415429 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/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
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 040593030
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil Accord 50 mg/ml Injektions-/ Infusionslösung
PRD1186032 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/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
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 89351.00.00
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FLUOROURACILE ACCORD 50 mg/ml, solution à diluer pour perfusion
PRD415412 · Product
- 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
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 34009 575 181 1 0
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracilo Accord 50 mg/ml solución inyectable o para perfusión EFG
PRD1972851 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2400 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
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 71.868
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracile AHCL 50 mg/ml, Soluzione per iniezione o infusione
PRD415430 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 040593042
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FLUOROURACILE ACCORD 50 mg/ml, solution à diluer pour perfusion
PRD415416 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2400 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
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 34009 575 182 8 8
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil Accord 50 mg/ml Injektions-/ Infusionslösung
PRD1186033 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 2400 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
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- 89351.00.00
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fondation Franc.Cancerologie Digestive
- Sponsor organisation
- Fondation Franc.Cancerologie Digestive
- Address
- 7 Boulevard Jeanne D Arc
- City
- Dijon
- Postcode
- 21000
- Country
- France
Scientific contact point
- Organisation
- Fondation Franc.Cancerologie Digestive
- Contact name
- coordinator
Public contact point
- Organisation
- Fondation Franc.Cancerologie Digestive
- Contact name
- coordinator
Locations
4 EU/EEA countries · 101 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 10 | 60 |
| Germany | Ongoing, recruiting | 9 | 15 |
| Italy | Ongoing, recruiting | 9 | 17 |
| Spain | Ongoing, recruiting | 9 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Hopital Saint Louis
Gastroenterology, 1 Avenue Claude Vellefaux, 75010, Paris
Institut De Cancerologie De L Ouest
Oncology, 15 Rue Andre Boquel, 49100, Angers
IHFB Cognacq Jay
Oncology, 4 Rue Kleber, 92300, Levallois-Perret
Centre Hospitalier Et Universitaire De Limoges
Oncology, 2 Avenue Martin Luther King, 87000, Limoges
Assistance Publique Hopitaux De Paris
Hepatogastroenterology, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier De Pau
Gastroenterology, 4 Boulevard Hauterive, 64000, Pau
Institut Mutualiste Montsouris
Gastroentérology, 42 Boulevard Jourdan, 75014, Paris
Hopital Europeen Marseille
Gastroenterology, 6 Rue Desiree Clary, 13003, Marseille
Centre Hospitalier Universitaire De Poitiers
Gastroenterology, 2 Rue De La Miletrie, 86000, Poitiers
Polyclinique Bordeaux Nord Aquitaine
Gastroenterology, 15 Rue Claude Boucher, Cs 31396, Bordeaux Cedex
Polyclinique Saint-Come
Oncology, 7 Rue Jean Jacques Bernard, 60200, Compiegne
Centre Hospitalier Simone Veil De Beauvais
Oncology, 40 Avenue Leon Blum, 60000, Beauvais
Clinique Tivoli Ducos
Oncology, 220 Rue Mandron, 33000, Bordeaux
Centre Hospitalier Regional Universitaire De Tours
Gastroenterology, 2 Boulevard Tonnelle, 37000, Tours
Unite De Recherche Clinique HIA Begin
Gastroenterology, 69 Avenue De Paris, 94160, Saint-Mande
CH Villefranche Nord Ouest
Gastroentérologue, Plateau d'Ouilly-Gleize, BP 80436, VILLEFRANCHE-SUR-SAONE
Centre Hospitalier Aunay Bayeux
Gastroentérologue, 13 rue de Nesmond, 14400, Bayeux
Centre Hospitalier Bethune Beuvry
Gastroenterology, 27 Rue Delbecque, 62660, Beuvry
Groupe Hospitalier Bretagne Sud
Gastroenterology, 5 Avenue Etienne Francois De Choiseul, 56100, Lorient
Groupe Hospitalier Rance Emeraude
Gastroenterology, 1 Rue De La Marne, 35403, Saint-Malo Cedex
Institut Godinot
Oncology, 1 Rue Du General Koenig, 51100, Reims
Hopital Prive D Antony
Gastroenterology, 1 Rue Velpeau, 92160, Antony
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
Oncology, 8 Rue Docteur Calmette, 38000, Grenoble
Assistance Publique Hopitaux De Paris
Gastroenterology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Institut De Cancerologie De Bourgogne
Gastroenterology, 18 Cours General De Gaulle, 21000, Dijon
Centre Hospitalier Universitaire De Caen Normandie
Gastroenterology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Icone
Oncology, 101 Avenue Francois Jacob, 51430, Bezannes
Hopital privé Le Bois
Oncology, 144 avenue de Dunkerque, 59000, Lille
Hoptial La Timone
Oncology, 264 rue Saint Pierre, 13005, Marseille
CHRU De Nancy
Gastroenterology, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Centre Hospitalier De Colmar
Gastroenterology, 39 Avenue De La Liberte, Bp 60535, Colmar Cedex
CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
Oncology, 10 Rue Francois Jacob, 22190, Plerin
Centr Georges Francois Leclerc
Oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Departemental Vendee
Gastroenterology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Institut De Cancerologie Strasbourg Europe
Gastroenterology, 17 Rue Albert Calmette, 67200, Strasbourg
Centre Hospitalier Regional Et Universitaire De Brest
Gastroenterology, 2 Avenue Marechal Foch, 29200, Brest
Centre Hospitalier Universitaire De Dijon
Gastroenterology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier De La Cote Basque
Gastroenterology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier Intercommunal De Cornouaille
Gastroenterology, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Centre Hospitalier De Cholet
Oncology, 1 Rue De Marengo, 49300, Cholet
Centre Hospitalier Annecy Genevois
Gastroenterology, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Hopital Prive Jean Mermoz
Gastroenterology, 55 Avenue Jean Mermoz, 69008, Lyon
Centre Hospitalier Universitaire Reims
Oncology, 45 Rue Cognacq Jay, 51100, Reims
Centre Hospitalier Regional Universitaire
Oncology, 2 Place Saint Jacques, Cs 51804, Besancon Cedex
Centre Hospitalier Prive Saint-Gregoire
Oncology, 6 Boulevard De La Boutiere, Cs 56816, Saint-Gregoire
Centre de Radiothérapie - Clinique Sainte Anne
Oncology, 184 Route de la Wantzenau, 67000, STRASBOURG
Centre Hospitalier Universitaire De Bordeaux
Gastroenterology, 66 Avenue De Magellan, 33608, Pessac Cedex
Groupe Hospitalier Nord Essonne
Oncology, 4 Place Du General Leclerc, 91400, Orsay
Centre Hospitalier General De St Denis
Oncology, 2 Rue Du Docteur Delafontaine, Bp 279, St Denis Cedex
Centre Hospitalier Henri Mondor
Oncology, 50 Avenue De La Republique, 15002, Aurillac Cedex
L'Hopital Prive Du Confluent
oncology, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2
Institut Regional Du Cancer De Montpellier
oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier Universitaire Rouen
hepatologist and gastroenterologist, 1 Rue De Germont, Bp 96031, Rouen Cedex
Pole Sante Leonard De Vinci
oncology, 1 Avenue Du Professeur Alexandre Minkowski, 37170, Chambray Les Tours
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
oncology, 185 Rue Raymond Losserand, 75014, Paris
Centre Hospitalier de Sens
Oncology, 1 avenue Pierre de Courbertin, 89100, Sens
Hopital Prive Sainte Marie Chalon
oncology, 4 Allee De Saint Jean Des Vignes, 71100, Chalon Sur Saone
Institut De Cancerologie De Lorraine
oncology, 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
Hospices Civils De Lyon
Hepatogastroenterology, 3 Quai Des Celestins, Bp 2251, Lyon Cedex 02
Centre De Cancerologue Du Grand Montpellier
oncology, 25 Rue De Clementville, 34070, Montpellier
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CVK), Augustenburger Platz 1, Wedding, Berlin
Kreiskliniken Reutlingen gGmbH
Medizinische Klinik I, Steinenbergstrasse 31, Ringelbach, Reutlingen
Universitaetsmedizin Goettingen
Klinik für Gastroenterologie, gastrointestinale Onkologie und Endokrinologie, Robert-Koch-Strasse 40, Weende, Goettingen
Katholisches Klinikum Bochum gGmbH
Klinik für Hämatologie und Onkologie mit Palliativmedizin, Gudrunstrasse 56, Grumme, Bochum
Krankenhaus Nordwest GmbH
Institute of Clincial Cancer Research, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Dr. Vehling-Kaiser MVZ GmbH
ÜBAG MVZ Dr. Vehling-Kaiser GmbH, Achdorfer Weg 5, Achdorf, Landshut
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH
Medizinische Klinik II, Gustav-Adolf-Strasse 8/6, Hochfeld-Steinberg, Schweinfurt
Klinikum Suedstadt Rostock Eigenbetrieb der Hanse und Universitaetsstadt Rostock
Klinik für Innere Medizin III, Suedring 81, Suedstadt, Rostock
ELBLANDKLINIKEN Stiftung & Co. KG
Hämatologie/ Onkologie/Palliativemedizin, Weinbergstrasse 8, Altriesa, Riesa
Universitaetsklinikum Schleswig-Holstein AöR
Clinic oh Internal Medicine II, Arnold-Heller-Strasse 3, Brunswik, Kiel
Technische Universitaet Dresden
Medizinische Klinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Stiftung Mathias-Spital Rheine
Mathias Spital Rheine, Frankenburgstrasse 1, Innenstadt, Rheine
Hämatologisch-Onkologische Praxis Eppendorf (Hope)
Norddeutsches Studienzentrum für Innovative Onkologie (NIO), Eppendorfer Landstraße 42, 20249, Hamburg
Gemeinschaftspraxis Haematologie Onkologie
Gemeinschaftspraxis Hämatologie-Onkologie Dresden, Arnoldstrasse 18, Johannstadt-Nord, Dresden
HELIOS Klinikum Bad Saarow GmbH
Clinic for Oncology and Palliative Care, Pieskower Strasse 33, 15526, Bad Saarow
Careggi University Hospital
Clinical Oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Casa Sollievo Della Sofferenza
Oncology, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Istituto Oncologico Veneto
Oncology, Via Gattamelata 64, 35128, Padova
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Medical Oncology, Via Piero Maroncelli 40, 47014, Meldola
Centro Di Riferimento Oncologico Di Aviano
Department of Medical Oncology and Oncological Prevention, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Medical Oncology, Viale Oxford 81, 00133, Rome
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Medical Oncology 1U, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Medical Oncology, Via Santa Sofia 78, 95123, Catania
Azienda USL Toscana Centro
Medical Oncology, Via Suor Niccolina Infermiera 20/22, 59100, Prato
Pia Fondazione Di Culto E Religione Card G Panico
Oncology, Via Pio X 4, 73039, Tricase
Azienda Sanitaria Universitaria Friuli Centrale
Oncology, Via Pozzuolo 330, 33100, Udine
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Oncology, Viale Vittorio Alfieri 36, 57124, Leghorn
Azienda Ospedaliero Universitaria Pisana
University Medical Oncology 2, Via Roma 67, 56126, Pisa
Azienda Ospedaliero-Universitaria Di Cagliari
Medical Oncology, Strada Statale 554 N. 1, 09042, Monserrato
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology, Via Giacomo Venezian 1, 20133, Milan
Azienda Unita Sanitaria Locale Della Romagna
Oncology, Viale Vincenzo Randi 5, 48121, Ravenna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department of Medical and Surgical Sciences, Largo Francesco Vito 1, 00168, Rome
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Central De Asturias
Oncology, Avenida De Roma S/n, 33011, Oviedo
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario De Navarra
Oncology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital General Universitario De Valencia
Oncology, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitario De Salamanca
Oncology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
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 | 2025-08-29 | 2025-11-21 | |||
| Germany | 2025-08-29 | 2026-03-02 | |||
| Italy | 2025-08-29 | 2025-10-02 | |||
| Spain | 2025-08-29 | 2026-01-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 56 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514030-20-00 redacted | 3.2 |
| Protocol (for publication) | D1_Protocol_2024-514030-20-00 TC redacted | 3.2 |
| Recruitment arrangements (for publication) | K1_recruitment arrangments | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangments_GER_final | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material description_Redacted | NA |
| Recruitment arrangements (for publication) | K2_recruitment material description_Spain_Final_20241114 | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing document questionnaire G8 FR | 1 |
| Subject information and informed consent form (for publication) | D4_Patient facing document questionnaire GCODE FR | 1 |
| Subject information and informed consent form (for publication) | D4_Patient facing document questionnaire GP5 FR | 1 |
| Subject information and informed consent form (for publication) | D4_Patient facing document treatment compliance diary | 1.1 |
| Subject information and informed consent form (for publication) | D4_Patient facing document treatment compliance diary TC | 1 |
| Subject information and informed consent form (for publication) | D4_Patient facing documents questionnaire QLQ C30 FR | 1 |
| Subject information and informed consent form (for publication) | L1_COLOSOTO_PIC_final_redacted_for publication | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults TC | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_spain | 2.0 |
| 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_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EORTC QLQ-C30_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_G CODE_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP5_Redacted | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ONCODAGE G8_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Diary_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Facing Document_compliance diary german_final_redacted_for publication | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Facing Document_Questionnaire_G-CODE_german_ not for publication | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Facing Document_Questionnaire_G-CODE_german_ redacted for publication | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Facing Document_Questionnaire_G8_german_final_ redacted_for publication | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Facing Document_Questionnaire_G8_german_final_ redacted_not for publication | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Facing Document_Questionnaire_GP5_german_final_not for publication | 4 |
| Subject information and informed consent form (for publication) | L3_Patient Facing Document_Questionnaire_GP5_german_final_redacted_for publication | 4 |
| Subject information and informed consent form (for publication) | L3_Patient Facing Document_Questionnaire_QLQC30_german_final_not for publication | 3 |
| Subject information and informed consent form (for publication) | L3_Patient Facing Document_Questionnaire_QLQC30_german_final_redacted_for publication | 4 |
| Subject information and informed consent form (for publication) | Other subject information material_G-CODE Version espanola | 1 |
| Subject information and informed consent form (for publication) | Other subject information material_GP5_SPA_Final_Ver4 | 4 |
| Subject information and informed consent form (for publication) | Other subject information material_ONCODAGE G8- Spanish | 1 |
| Subject information and informed consent form (for publication) | Other subject information material_Patient Diary_Redacted | 1 |
| Subject information and informed consent form (for publication) | Other subject information material_QLQ-C30-Spanish-Spain | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC FLUOROURACILE ACCORD FR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC FLUOROURACILE ACCORD FR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC HIKMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FLUOROURACIL ACCORD DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FLUOROURACIL ACCORD DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FLUOROURACIL ACCORD ES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Smpc FLUOROURACIL ACCORD ES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FLUOROURACIL ACCORD IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FLUOROURACIL ACCORD IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC VECTIBIX | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_LUMYKRAS | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FRANCE 2024-514030-20-00 TC redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FRANCE-2024-514030-20-00 redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis GERMANY 2024-514030-20-00 redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis GERMANY 2024-514030-20-00 TC redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ITALY 2024-514030-20-00 redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ITALY 2024-514030-20-00TC TC redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SPAIN 2024-514030-20-00 redacted | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SPAIN 2024-514030-20-00 TC redacted | 3.1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-19 | France | Acceptable 2025-03-24
|
2025-03-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-07 | France | Acceptable 2026-01-06
|
2026-01-07 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-11 | France | Acceptable 2026-01-06
|
2026-02-11 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-19 | Acceptable | 2026-03-26 |