Improving REsectability in Pancreatic NEoplasms (IRENE)

Overview

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

Full Title of Study: “Interventional Multicentric Study Without Medicine, in Patients Affected by Locally Advanced Pancreatic Adenocarcinoma: Stereotactic Radiotherapy.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: SBRT plus chemotherapy
    • Patients with unresectable or “borderline resectable” locally advanced pancreatic carcinoma at time of diagnosis

Clinical Trial Outcome Measures

Primary Measures

  • Clinical response to the treatment in terms of resectability
    • Time Frame: 24 months
    • Percentage of patients with pancreatic cancer judged to be inoperable who have undergone surgical treatment after neoadjuvant chemotherapy plus stereotactic body radiotherapy. Response is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria) by a multidisciplinary team of surgeons, radiologist, oncologist, radiation oncologist according to resectability criteria NCCN v. 2017.

Secondary Measures

  • Overall survival
    • Time Frame: 24 months
    • Months of survival since the diagnosis
  • Progression free survival
    • Time Frame: 24 months
    • Progression-free survival (PFS) after radiotherapy is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria). Also laboratory tests are performed (CA 19.9)
  • Toxicity
    • Time Frame: 24 months
    • Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03
  • Quality of life
    • Time Frame: 24 months
    • QoL are assessed with Cancer Linear Analog Scale (CLAS) which evaluating well-being, fatigue, and ability to perform daily activities (values range from 0 that represents the best status to 10 that represents the worst one)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alessio Giuseppe Morganti, Professor – IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Overall Official(s)
    • Alessio G Morganti, MD, Study Director, Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine – DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
  • Overall Contact(s)
    • Alessio G Morganti, MD, +390512143564, rt.unibo@gmail.com

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