Unresectable locally advanced, non-metastatic pancreatic cancer (as described by NCCN guidelines version 1.2022) MedDRA version: 21.1 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10052747 Term: Adenocarcinoma pancreas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: LOSARTAN DOC GENERICI - 12.5 MG COMPRESSE RIVESTITE CON FILM 21 COMPRESSE IN BLISTER PVC/PVDC/PELLICOLA DI ALLUMINIO
Product Name: Losartan DOC 12,5 mg
Product Code: [Losartan DOC 12, 5 m
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed pancreatic carcinoma 2. Clinical stage I-III, according to TNM 8th ed. 3. Locally advanced disease, as defined per NCCN Guidelines version 1.2022 (Appendix D) 4. Baseline systolic blood pressure (SBP) = 100 mmHg 5. Age >18 years and =75 years. 6. Life expectancy greater than 12 weeks. 7. ECOG performance status 0-2 (see Appendix A). 8. Presence of at least one measurable lesion in agreement to RECIST 1.1 criteria 9. Patients must have normal organ and marrow function 10. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 11. Ability to understand and the willingness to sign a written informed consent document. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: 1. Clinical stage IV, according to TNM 8th ed. 2. Patients who have previously received chemotherapy or radiotherapy for pancreatic cancer. 3. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agent used in the study. 5. Serious concomitant systemic disorders incompatible with the study (at discretion of the investigator); 6. Patient already treated on other Losartan dosages than those prescribed by protocol or treated on other Angiotensin II Receptor Blockers (ARB) therapy for hypertension or renal protection (with diabetes) at the time of enrolment; 7. Baseline hypotension, defined as systolic BP lower than 100 mmHg on two readings obtained on two separated days prior to study enrolment. 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Step A: To assess the safety of GEM-Nab-Paclitaxel and Losartan association followed by stereotactic radiation. Step B: To assess the activity, in terms of resectability rate, of the study treatment.;Secondary Objective: Margin-negative resection rate (R0), progression-free survival (PFS), overall survival (OS) blood biomarkers response, and safety and quality of life..;Primary end point(s): -Step A: Number of participants discontinuing study treatment due to treatment related G=3 AEs. Toxicity assessments will be done using the NCI Common Terminology Criteria for Adverse Events (CTCAE v 5.0). -Step B: Rate of patients undergoing surgery on total patient population. Resectability will be determined by Multidisciplinary team according.;Timepoint(s) of evaluation of this end point: 40 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): margin-negative resection rate (R0); blood biomarkers response; progression-free survival (PFS); overall survival (OS); safety; quality of life;Timepoint(s) of evaluation of this end point: 40 months; 80 months; 80 months; 80 months; 40 months; 40 months | — |
Countries
Italy
Contacts
Public ContactCentro di Coordinamento studi IRST
IRCCS IRST
Outcome results
None listed