Clinical trial NCT03822936: Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma
Official title: Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment with Chemotherapy and Carbon Ions Radiation Therapy (hadrontherapy)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer of Pancreas
Pancreas Adenocarcinoma
Resectable Pancreatic Cancer
Keywords: carbon ion radiation therapy
exocrine pancreas
pancreas tumour
Lead sponsor: CNAO National Center of Oncological Hadrontherapy
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2019-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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
* 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.

Primary outcomes:
measure: Progression free survival
timeFrame: The local progression free survival will be assessed at 1-year
Secondary outcomes:
measure: overall survival
timeFrame: The overall survival of enrolled patients will be assessed at 2-years
measure: resectability rate R0 stratified (operable vs not operable)
timeFrame: time of surgery (4-6 weeks after radiotherapy)
measure: Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity
timeFrame: 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.
measure: intra and perioperatory complications
timeFrame: The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: CNAO
Study officials:
affiliation: CNAO National Center of Oncological Hadrontherapy
name: Francesca Valvo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vitolo V, Cobianchi L, Brugnatelli S, Barcellini A, Peloso A, Facoetti A, Vanoli A, Delfanti S, Preda L, Molinelli S, Klersy C, Fossati P, Orecchia R, Valvo F. Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study. BMC Cancer. 2019 Sep 14;19(1):922. doi: 10.1186/s12885-019-6108-0.