Improving REsectability in Pancreatic NEoplasms (IRENE)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03460925
• Date of registration: 05/03/2018
• Prospective Registration: Yes
• Primary sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Public title: Improving REsectability in Pancreatic NEoplasms (IRENE) IRENE
• Scientific title: Interventional Multicentric Study Without Medicine, in Patients Affected by Locally Advanced Pancreatic Adenocarcinoma: Stereotactic Radiotherapy.
• Date of first enrolment: May 2, 2018
• Target sample size: 14
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03460925
• Study type: Interventional
• Study design: Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Italy

Contacts

• Name: Alessio G Morganti, MD

• Name: Alessio G Morganti, MD
• 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

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stereotactic Body Radiotherapy

Pancreatic Cancer

Intervention(s)

Radiation: SBRT plus chemotherapy

Primary Outcome(s)

Clinical response to the treatment in terms of resectability [Time Frame: 24 months]

Secondary Outcome(s)

Overall survival [Time Frame: 24 months]

Progression free survival [Time Frame: 24 months]

Toxicity [Time Frame: 24 months]

Quality of life [Time Frame: 24 months]

Secondary ID(s)

IRENE-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors