Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

Phase 2

Terminated

• Conditions: Pancreas Adenocarcinoma; Resectable Pancreatic Cancer; Cancer of Pancreas
• Interventions: Drug: Preoperative chemotherapy; Radiation: Preoperative radiotherapy

• Registration Number: NCT03822936
• Lead Sponsor: CNAO National Center of Oncological Hadrontherapy

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.

Study Timeline

• Study Start: 2018-02-08
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-30
• Primary Completion: 2022-08-08
• Status Verified: 2025-02
• Study Completion: 2025-02-10
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• histologic/cytologic diagnosis of exocrine pancreas tumour
• resectable or borderline resectable exocrine pancreatic tumour (according to operability criteria)
• no metastasis from US, CT, PET, MRI or laparotomy
• Karnofsky index >= 70
• stomach and duodenum not infiltrated by tumour
• given informed consent to study procedures
• Hb > 9 g/dL, N> 1500, PLT> 100000
• creatininemia < 1.5 mg/dL; bilirubinemia < 1.5 times upper normal values; albumin > 3 g/dL
• DPD normal activity
• contraception required and breast feeding not permitted

Exclusion Criteria

• non resectable, locally advanced tumours
• insular cells tumour
• comorbidities excluding abdominal surgery and/or chemo- radiation therapy
• known metastasis
• DPD low activity
• inability to attend study procedures and follow ups
• pregnancy
• previous diagnosis of other tumour with more disadvantageous prognosis then the study object
• metallic biliary stent
• metallic prothesis or any other condition to prevent from target volume individuation and dose calculation
• clinical condition preventing from radiation therapy (i.e. infections in the irradiation area)
• medical and/or psychical condition preventing from radiation therapy
• past radiation therapy on abdomen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preoperatory chemoradiation therapy with carbon ions	Preoperative chemotherapy	Chemoradiation followed by surgery
Preoperatory chemoradiation therapy with carbon ions	Preoperative radiotherapy	Chemoradiation followed by surgery

Primary Outcome Measures

Name	Time	Method
Progression free survival	The local progression free survival will be assessed at 1-year	The local progression free survival is measured

Secondary Outcome Measures

Name	Time	Method
resectability rate R0 stratified (operable vs not operable)	time of surgery (4-6 weeks after radiotherapy)	how many surgeries completed according to the procedures and with histopathological margins free from the disease/enrolled patients
overall survival	The overall survival of enrolled patients will be assessed at 2-years	the overall survival of enrolled patients is considered
Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity	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.	Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity
intra and perioperatory complications	The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days	intra and perioperatory complications

Trial Locations

Locations (1)

CNAO; 🇮🇹 Pavia, Italy