Improving REsectability in Pancreatic NEoplasms (IRENE)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Stereotactic Body Radiotherapy; Pancreatic Cancer

Treatments: Radiation: SBRT plus chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03460925

IRENE-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

14 participants in 1 patient group

SBRT plus chemotherapy

Experimental group

Description:

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

Treatment:

Radiation: SBRT plus chemotherapy