Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
116
Countries
1
Sites
22
Resectable pancreatic adenocarcinoma with risk factors
To evaluate, in patients diagnosed with resectable pancreatic adenocarcinoma with risk factors who complete neoadjuvant treatment with mFOLFIRINOX and radiotherapy, surgery and then adjuvant chemotherapy, the overall survival (OS) data. And compare OS data with those obtained in a group of control patients who will be…
Key facts
- Sponsor
- La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Oct 2021 → 18 Dec 2025
- Decision date (initial)
- 2024-11-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Instituto de Salud Carlos III - Grant (beca)
External identifiers
- EU CT number
- 2024-519633-35-00
- EudraCT number
- 2021-000317-17
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate, in patients diagnosed with resectable pancreatic adenocarcinoma with risk factors who complete neoadjuvant treatment with mFOLFIRINOX and radiotherapy, surgery and then adjuvant chemotherapy, the overall survival (OS) data.
And compare OS data with those obtained in a group of control patients who will be treated with surgery plus mFOLFIRINOX adjuvant chemotherapy.
Secondary objectives 8
- Assess invasive disease-free survival
- Assess cycle completions.
- Evaluate local and metastatic relapses
- Assess post-surgical morbidity and mortality.
- Assess R0 resection rates
- Evaluate safety of neoadjuvant treatment.
- To assess intention-to-treat patients.
- Assess patient quality of life.
Conditions and MedDRA coding
Resectable pancreatic adenocarcinoma with risk factors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10033602 | Pancreatic adenocarcinoma resectable | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | SURVIVAL ANALYSIS AFTER NEOADJUVANT TREATMENT IN RESECTABLE PANCREATIC CANCER WITH RISK FACTORS Open, randomised, controlled, prospective, multicentre study to evaluate the efficacy and safety of neoadjuvant chemotherapy administered in conjunction with surgery plus adjuvant therapy in patients with resectable pancreatic adenocarcinoma with risk factors.
|
Randomised Controlled | None | Study Group: mFolfirinox and fractionated stereotactic radiotherapy + surgery + adjuvant chemotherapy (mFolfirinox). Control Group: Surgery + adjuvant chemotherapy (mFolfirinox) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Patients diagnosed with resectable adenocarcinoma of the pancreas and with at least 2 risk factors.
- Histological diagnosis of pancreatic adenocarcinoma by fine needle aspiration puncture performed by endoscopic ultrasound.
- Patients who have not received prior therapy for pancreatic cancer.
- ECOG < 2
- Biliary drainage prior to neoadjuvant if required (bilirubin levels > 1.5 mg/dl x LSN.
- Age > 18 years and < 70 years. Patients between 71 and 75 years of age (both included) will be allowed to be included by applying the GERIATRIC 8 (G8) frailty test. If the result of the GERIATRIC 8 (G8) frailty test is GREATER THAN 14 POINTS, THE PATIENT WILL BE CONSIDERED ‘NOT FRAGILE’ AND THEREFORE MAY BE INCLUDED IN THE STUDY. See ANNEX 24, GERIATRIC-8 test.
- No history of cerebrovascular accident or myocardial infarction in 6 months prior to neoadjuvant treatment.
- Women of childbearing age and sexually active men must agree to use adequate contraception (hormonal, barrier or abstinence method of contraception) prior to study inclusion and during study participation.
- Patients must have normal organ and marrow function.
- Ability to understand, and willingness to sign a written informed consent document.
Exclusion criteria 15
- Patients with resectable adenocarcinoma of the pancreas without risk factors.
- Patients with borderline pancreatic adenocarcinoma.
- Patients with locally advanced pancreatic adenocarcinoma.
- Patients with metastatic pancreatic adenocarcinoma.
- Patients who have received prior chemotherapy or radiotherapy for pancreatic adenocarcinoma.
- Pathological subtypes other than adenocarcinoma.
- Patients included in a clinical trial involving the taking of medication within 6 months prior to inclusion in this study.
- History of allergic reaction attributed to 5-FU, leucovorin, Irinotecan or Oxaliplatin or to compounds of similar chemical or biological composition. Exception: those patients who at the start of treatment present a hypersensitivity reaction and the desensitisation protocol is applied following standard practice may continue in the study.
- Uncontrolled intercurrent illness.
- HIV-, HBV- and HCV-positive patients currently on combination antiretroviral therapy.
- Other active neoplasms
- Pre-existing neuropathy.
- Inflammatory bowel disease that is uncontrolled, or is under current active treatment.
- Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency. In patients with this deficiency, the fluoropyrimidine dosage will be adjusted according to the pharmacokinetic analysis of DPD variants. This adjustment is carried out in clinical practice from the hospital pharmacy.
- Patients who do not meet the dosimetric restriction criteria detailed in the neoadjuvant radiotherapy section of this protocol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall Survival: Time a patient lives from the date of treatment initiation to exitus. The start date of treatment will be the date of surgery (in case of patients in the control arm) or the date of cycle 1 of chemotherapy (in case of patients in the experimental arm).
Secondary endpoints 9
- Invasive disease-free survival and event-free survival: The time a patient lives (or survives) without relapse of invasive disease after treatment (number of months until local or metastatic disease relapse). Whether the relapse is local or metastatic shall be specified.
- Number of cycles completed by patients.
- Monitoring of the appearance of new lesions.
- CA19,9 levels.
- Types of post-surgical events. Clavien-Dindo (C-D) classification and the 2016 update International Study Group of Pancreatic Fistula (ISGPF) classification. Delayed Gastric Emptying (DGE) and post-surgical bleeding classification ISGPF 2007.
- R0 resection rates.
- Number and nature of adverse events
- Number and/or percentage of patients with intention to treat.
- QLQ-C30 quality of life questionnaire
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 85 mg/m2 milligram(s)/sq. meter
- Max total dose
- 85 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 44 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06052MIG · Substance
- Active substance
- Calcium Folinate
- Pharmaceutical form
- SOLUTION FOR INJECTION OR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 44 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08295MIG · Substance
- Active substance
- Irinotecan
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 150 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 44 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 INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 44 Week(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
La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz
- Sponsor organisation
- La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz
- Address
- Avenida De Ana De Viya 21
- City
- Cadiz
- Postcode
- 11009
- Country
- Spain
Scientific contact point
- Organisation
- La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz
- Contact name
- Irene Andria Retes
Public contact point
- Organisation
- La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz
- Contact name
- Irene Andria Retes
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Servicio De Asesoria A La Investigacion Y Logistica S.L. ORG-100052817
|
Barcelona, Spain | Other |
Locations
1 EU/EEA country · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 116 | 22 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Puerta Del Mar
Surgery, Avenida De Ana De Viya 21, 11009, Cadiz
Hospital Universitario De La Princesa
Surgery, Calle De Diego De Leon 62, 28006, Madrid
University Hospital Virgen Del Rocio S.L.
Surgery, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario De Puerto Real
Surgery, Carretera Nacional IV Km 665 S/N, 11510, Puerto Real
Hospital Universitario De Badajoz
Surgery, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitario Miguel Servet
Surgery, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Y Politecnico La Fe
Surgery, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Surgery, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Complejo Hospitalario Universitario Insular Materno Infantil
Surgery, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Complexo Hospitalario Universitario De Vigo
Surgery, Estrada Clara Campoamor N 341, 36312, Vigo
Hospital Royo Villanova
Surgery, Avenida De San Gregorio 30, 50015, Zaragoza
Hospital Universitario Regional De Malaga
Surgery, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Juan Ramon Jimenez
Surgery, Ronda Exterior Norte S/n, 21005, Huelva
Hospital Universitario Virgen De La Macarena
Surgery, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Rio Hortega
Surgery, Calle Dulzaina 2, 47012, Valladolid
El Hospital Universitario De Gran Canaria Dr. Negrin
Surgery, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Lucus Augusti
Surgery, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital General Universitario Morales Meseguer
Surgery, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital De La Santa Creu I Sant Pau
Surgery, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario De Cabuenes
Surgery, Calle Prados 395, Cabuenes, Gijon
Hospital Universitario Donostia
Surgery, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitario Virgen De Valme
Surgery, Avenida Bellavista S/n, 41014, Sevilla
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 |
|---|---|---|---|---|---|
| Spain | 2021-10-25 | 2022-06-13 | 2025-05-31 |
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
| Title | Submission date | Status | Type |
|---|---|---|---|
| Results of the study SUM-135834
|
2026-05-26T10:26:44 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of results | 2026-05-26T10:26:37 | Submitted | Laypersons Summary of Results |
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Q2_LaySummary_ES | 1 |
| Protocol (for publication) | Protocol_2024-519633-35_v5_1 Sep 2023_SP | 5 |
| Recruitment arrangements (for publication) | Procedimientos y material 2024-519633-35 v1_2021May05 fP | 1 |
| Subject information and informed consent form (for publication) | HIP_CI 2024-519633-35 v 2_2021_07_15 fP | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC 5FU_2024-519633-35_1Feb2021_SP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Folinato calcico_2024-519633-35_1Feb2021_SP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Irinotecan_2024-519633-35_1Feb2021_SP | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Oxaliplatino_2024-519633-35_1Feb2021_SP | 1 |
| Summary of results (for publication) | Q3_ResultsSummary_EUCT2024-519633-35-00 | 1 |
| Synopsis of the protocol (for publication) | Summary Protocol_2024-519633-35_v5_1 Sep 2023_SP | 5 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-22 | Spain | Acceptable with conditions 2024-11-28
|
2024-11-28 |