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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03822936
Study type Interventional
Source CNAO National Center of Oncological Hadrontherapy
Contact Francesca Valvo, MD
Phone 0039(0)382078501
Email francesca.valvo@cnao.it
Status Recruiting
Phase Phase 2
Start date February 8, 2018
Completion date February 8, 2023

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