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Folfirinox

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

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

SBRT plus chemotherapy

Alessio G Morganti, MD

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

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.

Improving REsectability in Pancreatic NEoplasms (IRENE)

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

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.

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)

Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Improving REsectability in Pancreatic NEoplasms (IRENE)	NCT03460925	Pancreatic Canc... Stereotactic Bo...	SBRT plus chemo...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Improving REsectability in Pancreatic NEoplasms (IRENE)	NCT03460925	Pancreatic Canc... Stereotactic Bo...	SBRT plus chemo...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna

Spots Global Cancer Trial Database for sbrt plus chemotherapy