Clinical trial · Interventional
Improving REsectability in Pancreatic NEoplasms (IRENE)
Interventional Multicentric Study Without Medicine, in Patients Affected by Locally Advanced Pancreatic Adenocarcinoma: Stereotactic Radiotherapy.
NCT03460925CI-TRIAL-00033137IRENEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of clinical response in terms of resectability of patients with locally advanced pancreatic cancer treated with neoadjuvant chemotherapy plus stereotactic body radiotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Stereotactic Body Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT plus chemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT plus chemotherapy
- description
- Patients with unresectable or "borderline resectable" locally advanced pancreatic carcinoma at time of diagnosis
- interventionNames
- Radiation: SBRT plus chemotherapy
Primary outcomes (1)
- measure
- Clinical response to the treatment in terms of resectability
- timeFrame
- 24 months
- description
- 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 outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.