Pancreatic Cancer Research

Clinical trialPhase 2Terminated

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)

NCT03822936↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Stopped earlyThe study was early closed due to low accrual in August 2022. (Enrollment)
Phase
Phase 2
Status
Terminated
Study type
Interventional
Start
8 February 2018
Expected end
10 February 2025
Enrollment
30 participants
Sites
1
Primary outcomes
Progression free survival
Sponsor
Other
Results posted
No
Last update
13 February 2025

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Brief summary public domain (ClinicalTrials.gov)

Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.

Detailed description public domain (ClinicalTrials.gov)

Enrolled subjects will undergo to 3 cycles of Folfirinox before re-evaluation of the lesion. Then, 4D planning and imaging with respiratory gating end rescanning technique will be adopted to calculate the optimal treatment plan to carbon ions radiation therapy: 38.4 Gy\[RBE\] is the prescribed dose to CTV. 4.8 Gy\[RBE\]/fraction will be delivered 4 times a week in two weeks. 4/6 weeks after hadrontherapy, after a CT scan with contrast, patient will undergo to a surgery. After 4/6 weeks, Gemcitabine will be administered for 6 cycles. Secondary endpoints of the trial are overall survival, resectability rate (operable vs borderline operable), acute toxicity within 3 months, 3-6 months, over 6 months.

Papers 2