SURVIVAL ANALYSIS AFTER NEOADJUVANT TREATMENT IN RESECTABLE PANCREATIC CANCER WITH RISK FACTORS

Trial details

Who runs it

La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz

Trial code

EU 2024-519633-35-00

Record updated

2024. november 28.

Original description

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.Read full original descriptionShow less

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.

Inclusion: Patients diagnosed with resectable adenocarcinoma of the pancreas and with at least 2 risk factors; Ability to understand, and willingness to sign a written informed consent document; 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.

Exclusion: HIV-, HBV- and HCV-positive patients currently on combination antiretroviral therapy; Patients who do not meet the dosimetric restriction criteria detailed in the neoadjuvant radiotherapy section of this protocol; Patients who have received prior chemotherapy or radiotherapy for pancreatic adenocarcinoma; Patients included in a clinical trial involving the taking of medication within 6 months prior to inclusion in this study; Inflammatory bowel disease that is uncontrolled, or is under current active treatment; 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; Patients with resectable adenocarcinoma of the pancreas without risk factors; Other active neoplasms; Pre-existing neuropathy; 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 with borderline pancreatic adenocarcinoma; Patients with locally advanced pancreatic adenocarcinoma; Patients with metastatic pancreatic adenocarcinoma; Pathological subtypes other than adenocarcinoma.

EU CTIS 2024-519633-35-00