PIOPPO: Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

Sponsor

CNAO National Center of Oncological Hadrontherapy (Other)

Overall Status

Recruiting

CT.gov ID

NCT03822936

Collaborator

Foundation IRCCS San Matteo Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer of Pancreas Pancreas Adenocarcinoma Resectable Pancreatic Cancer	Drug: Preoperative chemotherapy Radiation: Preoperative radiotherapy	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The trial enrolls subjects that will receive in order: chemotherapy, carbon ion therapy, followed by surgical resection after 4/6 weeks then adjuvant chemotherapy.The trial enrolls subjects that will receive in order: chemotherapy, carbon ion therapy, followed by surgical resection after 4/6 weeks then adjuvant chemotherapy.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment With Chemotherapy and Carbon Ions Radiation Therapy (Hadrontherapy)

Actual Study Start Date :

Feb 8, 2018

Anticipated Primary Completion Date :

Feb 8, 2023

Anticipated Study Completion Date :

Feb 8, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Preoperatory chemoradiation therapy with carbon ions Chemoradiation followed by surgery	Drug: Preoperative chemotherapy Preoperative chemotherapy, carbon ion therapy, surgery Other Names: Folinic acid, Irinotecan, fluorouracil, oxaliplatin Radiation: Preoperative radiotherapy Preoperative chemotherapy, carbon ion therapy, surgery Other Names: Carbon ion therapy

Arm

Intervention/Treatment

Experimental: Preoperatory chemoradiation therapy with carbon ions

Chemoradiation followed by surgery

Drug: Preoperative chemotherapy

Preoperative chemotherapy, carbon ion therapy, surgery

Other Names:

Folinic acid, Irinotecan, fluorouracil, oxaliplatin

Radiation: Preoperative radiotherapy

Preoperative chemotherapy, carbon ion therapy, surgery

Other Names:

Carbon ion therapy

Outcome Measures

Primary Outcome Measures

Progression free survival [The local progression free survival will be assessed at 1-year]
The local progression free survival is measured

Secondary Outcome Measures

overall survival [The overall survival of enrolled patients will be assessed at 2-years]
the overall survival of enrolled patients is considered
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.