Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma (PIOPPO)

CNAO National Center of Oncological Hadrontherapy

Status and phase: Terminated; Phase 2

Conditions: Resectable Pancreatic Cancer; Pancreas Adenocarcinoma; Cancer of Pancreas

Treatments: Drug: Preoperative chemotherapy; Radiation: Preoperative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03822936

CNAO 35/2017 C

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Preoperatory chemoradiation therapy with carbon ions

Experimental group

Description:

Chemoradiation followed by surgery

Treatment:

Radiation: Preoperative radiotherapy

Drug: Preoperative chemotherapy