NCT03822936

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: CNAO National Center of Oncological Hadrontherapy · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer of Pancreas
• Pancreas Adenocarcinoma
• Resectable Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Preoperative chemotherapy	Preoperative chemotherapy, carbon ion therapy, surgery
RADIATION	Preoperative radiotherapy	Preoperative chemotherapy, carbon ion therapy, surgery

Timeline

• Start date: 2018-02-08
• Primary completion: 2022-08-08
• Completion: 2025-02-10
• First posted: 2019-01-30
• Last updated: 2025-02-13

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study