Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Preoperative chemotherapy, carbon ion therapy, surgery
Preoperative chemotherapy, carbon ion therapy, surgery
CNAO
Pavia, Pavia, Italy
Progression free survival
The local progression free survival is measured
Time frame: The local progression free survival will be assessed at 1-year
overall survival
the overall survival of enrolled patients is considered
Time frame: The overall survival of enrolled patients will be assessed at 2-years
resectability rate R0 stratified (operable vs not operable)
how many surgeries completed according to the procedures and with histopathological margins free from the disease/enrolled patients
Time frame: time of surgery (4-6 weeks after radiotherapy)
Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity
Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity
Time frame: The incidence of acute and medium term toxicity will be assessed up to 90 and 180 post-operative days respectively. The incidence of late toxicity will be assessed through study completion, an average of 1 year.
intra and perioperatory complications
intra and perioperatory complications
Time frame: The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days
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