Improving REsectability in Pancreatic NEoplasms (IRENE)

Pancreatic Cancer Clinical Trial

— IRENE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03460925
• Other study ID #: IRENE-1
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: May 2018
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Alessio G Morganti, MD
• Phone: +390512143564
• Email: rt.unibo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Stereotactic Body Radiotherapy

Intervention

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

Locations

Country	Name	City	State
Italy	Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	Months of survival since the diagnosis	24 months
Secondary	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
Secondary	Toxicity	Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03	24 months
Secondary	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