Cancer of Pancreas, Pancreas Adenocarcinoma, Resectable Pancreatic Cancer
Conditions
Keywords
carbon ion radiation therapy, exocrine pancreas, pancreas tumour
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.
Interventions
Preoperative chemotherapy, carbon ion therapy, surgery
RADIATIONPreoperative radiotherapy
Preoperative chemotherapy, carbon ion therapy, surgery
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
CNAO National Center of Oncological Hadrontherapy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | The local progression free survival will be assessed at 1-year | The local progression free survival is measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed