Improving REsectability in Pancreatic NEoplasms (IRENE) (IRENE)

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

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

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer; Stereotactic Body Radiotherapy
• Intervention / Treatment: Radiation: SBRT plus chemotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessio G Morganti, MD; Phone Number: +390512143564; Email: rt.unibo@gmail.com

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital
    • Contact: G
    • Contact: Alessio G Morganti, MD; Phone Number: +390512143564; Email: rt.unibo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT plus chemotherapy; Patients with unresectable or "borderline resectable" locally advanced pancreatic carcinoma at time of diagnosis	Radiation: SBRT plus chemotherapy; Neoadjuvant stereotactic body radiotherapy (SBRT, 30 Gy in 5 fractions) plus chemotherapy with Folfirinox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response to the treatment in terms of resectability	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Months of survival since the diagnosis	24 months
Progression free survival	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)	24 months
Toxicity	Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03	24 months
Quality of life	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)	24 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Study Director: Alessio G Morganti, MD, Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: pancreatic cancer; stereotactic body radiotherapy; resectability
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: IRENE-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No