2024-519633-35-00
Not yet recruiting
Phase 4
SURVIVAL ANALYSIS AFTER NEOADJUVANT TREATMENT IN RESECTABLE PANCREATIC CANCER WITH RISK FACTORS
La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz22 sites in 1 country116 target enrollmentNovember 28, 2024
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz
- Enrollment
- 116
- Locations
- 22
- Primary Endpoint
- 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).
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Irene Andria Retes
Scientific
La Fundacion Para La Gestion De La Investigacion Biomedica De Cadiz
Eligibility Criteria
Inclusion 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.
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
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).
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 Outcomes
- CA19,9 levels.
- 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.
- 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
Study Sites (22)
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