Spots Global Cancer Trial Database for Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

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Trial Identification

Brief Title: Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

Official Title: Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment With Chemotherapy and Carbon Ions Radiation Therapy (Hadrontherapy)

Study ID: NCT03822936

Conditions

Cancer of Pancreas

Pancreas Adenocarcinoma

Resectable Pancreatic Cancer

Interventions

Preoperative chemotherapy

Preoperative radiotherapy

Study Description

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

Detailed Description: 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.