Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment with Chemotherapy and Carbon Ions Radiation Therapy (hadrontherapy)
Overview
- Phase
- Phase 2
- Intervention
- Preoperative chemotherapy
- Conditions
- Cancer of Pancreas
- Sponsor
- CNAO National Center of Oncological Hadrontherapy
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Progression free survival
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Francesca Valvo
Principal investigator
CNAO National Center of Oncological Hadrontherapy
Eligibility 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
Arms & Interventions
Preoperatory chemoradiation therapy with carbon ions
Chemoradiation followed by surgery
Intervention: Preoperative chemotherapy
Preoperatory chemoradiation therapy with carbon ions
Chemoradiation followed by surgery
Intervention: Preoperative radiotherapy
Outcomes
Primary Outcomes
Progression free survival
Time Frame: The local progression free survival will be assessed at 1-year
The local progression free survival is measured
Secondary Outcomes
- resectability rate R0 stratified (operable vs not operable)(time of surgery (4-6 weeks after radiotherapy))
- overall survival(The overall survival of enrolled patients will be assessed at 2-years)
- 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.)
- intra and perioperatory complications(The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days)