Clinical Trials Directory

Trials / Unknown

UnknownNCT03460925

Improving REsectability in Pancreatic NEoplasms (IRENE)

Interventional Multicentric Study Without Medicine, in Patients Affected by Locally Advanced Pancreatic Adenocarcinoma: Stereotactic Radiotherapy.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
14 (estimated)
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Evaluation of clinical response in terms of resectability of patients with locally advanced pancreatic cancer treated with neoadjuvant chemotherapy plus stereotactic body radiotherapy.

Detailed description

Aim of the study is to define the percentage of patients with down-staging and clinical response after having undergone stereotactic radiotherapy + chemotherapy with neoadjuvant intent for locally advanced pancreatic carcinoma or "borderline resectable" at the time of diagnosis. The study evaluates the response to therapy in terms of resectability, of acute and delayed treatment-related toxicity, of overall survival and progression-free survival and also assesses patient's quality of life.

Conditions

Interventions

TypeNameDescription
RADIATIONSBRT plus chemotherapyNeoadjuvant stereotactic body radiotherapy (SBRT, 30 Gy in 5 fractions) plus chemotherapy with Folfirinox

Timeline

Start date
2018-05-02
Primary completion
2020-01-01
Completion
2021-01-01
First posted
2018-03-09
Last updated
2018-05-30

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03460925. Inclusion in this directory is not an endorsement.