Clinical trial NCT03460925: Improving REsectability in Pancreatic NEoplasms (IRENE)
Official title: Interventional Multicentric Study Without Medicine, in Patients Affected by Locally Advanced Pancreatic Adenocarcinoma: Stereotactic Radiotherapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Stereotactic Body Radiotherapy
Keywords: pancreatic cancer
stereotactic body radiotherapy
resectability
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical response to the treatment in terms of resectability
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Progression free survival
timeFrame: 24 months
measure: Toxicity
timeFrame: 24 months
measure: Quality of life
timeFrame: 24 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G Morganti, MD
role: STUDY_DIRECTOR
References: