A Phase 2 interventional study of Preoperative chemotherapy and Preoperative radiotherapy in Cancer of Pancreas, Pancreas Adenocarcinoma and Resectable Pancreatic Cancer, sponsored by CNAO National Center of Oncological Hadrontherapy. Terminated at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by CNAO National Center of Oncological Hadrontherapy · Phase 2, Interventional, and Treatment
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 30 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →CNAO National Center of Oncological Hadrontherapy is the lead sponsor of 11 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Chemoradiation followed by surgery
Drug: Preoperative chemotherapy · Radiation: Preoperative radiotherapy
Preoperative chemotherapy, carbon ion therapy, surgery
Also known as: Folinic acid, Irinotecan, fluorouracil, oxaliplatin
Preoperative chemotherapy, carbon ion therapy, surgery
Also known as: Carbon ion therapy
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
Plan to share: No
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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CNAO National Center of Oncological Hadrontherapy