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SURVIVAL ANALYSIS AFTER NEOADJUVANT TREATMENT IN RESECTABLE PANCREATIC CANCER WITH RISK FACTORS
EU CTIS ID: 2024-519633-35-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Patients with resectable adenocarcinoma of the pancreas without risk factors.
- 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.
See the full eligibility criteria
- 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.
- Patients with resectable adenocarcinoma of the pancreas without risk factors.
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.