Clinical trial · Interventional
Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma
Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment with Chemotherapy and Carbon Ions Radiation Therapy (hadrontherapy)
NCT03822936CI-TRIAL-00085943PIOPPOterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was early closed due to low accrual in August 2022.
Summary
Brief summary (as posted)
Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
| Pancreas Adenocarcinoma | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Resectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative chemotherapy | Drug | — | UNRESOLVED |
| Preoperative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preoperatory chemoradiation therapy with carbon ions
- description
- Chemoradiation followed by surgery
- interventionNames
- Drug: Preoperative chemotherapy
- Radiation: Preoperative radiotherapy
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- The local progression free survival will be assessed at 1-year
- description
- The local progression free survival is measured
Secondary outcomes (4)
- measure
- overall survival
- timeFrame
- The overall survival of enrolled patients will be assessed at 2-years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologic/cytologic diagnosis of exocrine pancreas tumour * resectable or borderline resectable exocrine pancreatic tumour (according to operability criteria) * no metastasis from US, CT, PET, MRI or laparotomy * Karnofsky index \>= 70 * stomach and duodenum not infiltrated by tumour * given informed consent to study procedures * Hb \> 9 g/dL, N\> 1500, PLT\> 100000 * creatininemia \< 1.5 mg/dL; bilirubinemia \< 1.5 times upper normal values; albumin \> 3 g/dL * DPD normal activity * contraception required and breast feeding not permitted Exclusion Criteria: * non resectable, locally advanced tumours * insular cells tumour * comorbidities excluding abdominal surgery and/or chemo- radiation therapy * known metastasis * DPD low activity * inability to attend study procedures and follow ups * pregnancy * previous diagnosis of other tumour with more disadvantageous prognosis then the study object * metallic biliary stent * metallic prothesis or any other condition to prevent from target volume individuation and dose calculation * clinical condition preventing from radiation therapy (i.e. infections in the irradiation area) * medical and/or psychical condition preventing from radiation therapy * past radiation therapy on abdomen.
References
Publications (2)
- DERIVEDBarcellini A, Molinelli S, Vanoli A, Vitolo V, Fossati P, Vai A, Pagani A, Inzani F, Pecorilla M, Butturini G, Klersy C, Preda L, Facoetti A, Valvo F, Orlandi E. Preoperative chemo-CIRT in Re/BRe pancreatic cancer: Insights from a multicenter prospective phase II clinical study (NCT03822936). Tumori. 2024 Dec;110(6):470-474. doi: 10.1177/03008916241291341. Epub 2024 Oct 27. PMID 39462835
- DERIVEDVitolo V, Cobianchi L, Brugnatelli S, Barcellini A, Peloso A, Facoetti A, Vanoli A, Delfanti S, Preda L, Molinelli S, Klersy C, Fossati P, Orecchia R, Valvo F. Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study. BMC Cancer. 2019 Sep 14;19(1):922. doi: 10.1186/s12885-019-6108-0. PMID 31521134