Status:
UNKNOWN
Improving REsectability in Pancreatic NEoplasms (IRENE)
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Pancreatic Cancer
Stereotactic Body Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
NA
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 adv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03460925
Start Date
May 2 2018
End Date
January 1 2021
Last Update
May 30 2018
Active Locations (1)
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1
Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Bologna, Italy, 40138