Improving REsectability in Pancreatic NEoplasms (IRENE)
- Conditions
- Pancreatic CancerStereotactic Body Radiotherapy
- Interventions
- Radiation: SBRT plus chemotherapy
- Registration Number
- NCT03460925
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 14
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SBRT plus chemotherapy SBRT plus chemotherapy Patients with unresectable or "borderline resectable" locally advanced pancreatic carcinoma at time of diagnosis
- Primary Outcome Measures
Name Time Method Clinical response to the treatment in terms of resectability 24 months 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.
- Secondary Outcome Measures
Name Time Method Overall survival 24 months Months of survival since the diagnosis
Progression free survival 24 months 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)
Toxicity 24 months Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03
Quality of life 24 months 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)
Trial Locations
- Locations (1)
Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital
🇮🇹Bologna, Italy