Improving REsectability in Pancreatic NEoplasms (IRENE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2021-01-01

Brief Summary

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

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Detailed Description

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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

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Pancreatic Cancer Stereotactic Body Radiotherapy

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT plus chemotherapy

Patients with unresectable or "borderline resectable" locally advanced pancreatic carcinoma at time of diagnosis

Group Type EXPERIMENTAL

SBRT plus chemotherapy

Intervention Type RADIATION

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

Interventions

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SBRT plus chemotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* histological diagnosis of locally advanced pancreatic carcinoma, not upfront surgically treated (according to NCCN resectability criteria), without distant metastases
* NCCN criteria resectability status
* patient's age, performance status, possible presence of comorbidity should also be considered to decide the optimal approach (upfront surgery versus neoadjuvant treatment).
* If the chemotherapy treatment induces the disease to a condition of resectability, the patient will undergo a surgical evaluation
* indication for radiotherapy treatment
* ECOG 0-2
* obtaining informed consent
* not pregnant or breastfeeding

Exclusion Criteria

* ECOG\> 2
* presence of internal diseases for which radiotherapy is contraindicated, or diseases of the connective system, or gastric or duodenal ulcer in progress or acute diverticulitis, ulcerative colitis
* comorbidity which in the opinion of the referring physician may constitute a risk for participation in the study
* lack of availability for clinical-instrumental follow-up
* previous abdominal radiotherapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Alessio Giuseppe Morganti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessio G Morganti, MD

Role: STUDY_DIRECTOR

Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy