Trial | NCT03822936  Report issue

Title

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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
Study Started
Feb 08
2018
Primary Completion
Feb 08
2023
Anticipated
Study Completion
Feb 08
2023
Anticipated
Last Update
Sep 05
2021

Drug Preoperative chemotherapy [aldoxorubicin, ifosfamide (ifex)]

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

Preoperatory chemoradiation therapy with carbon ions Experimental

Chemoradiation followed by surgery

Criteria 

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.
No Results Posted