Improving REsectability in Pancreatic NEoplasms (IRENE)

Study Overview
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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.

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.

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

Conditions
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Pancreatic Cancer, Stereotactic Body Radiotherapy

Intervention / Treatment
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* Radiation: SBRT plus chemotherapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, stereotactic body radiotherapy, resectability