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IORT on Borderline Resectable Pancreatic Cancer

NCT04090463 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-07

No results posted yet for this study

Summary

This phase II study investigates the efficacy of IORT for patients with borderline resectable pancreatic cancer. The purpose of the study is to investigate whether the addition of IORT, after FOLOFIRINOX-base chemotherapy, and SBRT, increases the 3-year survival rate. A total of 101 patients will be enrolled, and these patients will receive IORT of 10 to 20 Gy, according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).

Conditions

Interventions

RADIATION

Intraoperative radiotherapy

IORT will be delivered as follows: 1. Radical resection --\> delivery of 10-15 Gy to the tumor bed 2. Non radical resection --\> delivery of 15-20 Gy to the tumor "in situ"

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2027-10-30
Completion
2027-12-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090463 on ClinicalTrials.gov