Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

Cancer of Pancreas Clinical Trial

— PIOPPO  

Official title:

Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment With Chemotherapy and Carbon Ions Radiation Therapy (Hadrontherapy)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03822936
• Other study ID #: CNAO 35/2017 C
• Status: Recruiting
• Phase: Phase 2
• Start date: February 8, 2018
• Est. completion date: February 8, 2023

Study information

• Verified date: August 2021
• Source: CNAO National Center of Oncological Hadrontherapy
• Contact: Francesca Valvo, MD
• Phone: 0039(0)382078501
• Email: francesca.valvo[@]cnao.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 8, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Cancer of Pancreas
• Pancreas Adenocarcinoma
• Pancreatic Neoplasms
• Resectable Pancreatic Cancer

Intervention

Drug:
• Preoperative chemotherapy
Preoperative chemotherapy, carbon ion therapy, surgery

Radiation:
• Preoperative radiotherapy
Preoperative chemotherapy, carbon ion therapy, surgery

Locations

Country	Name	City	State
Italy	CNAO	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
CNAO National Center of Oncological Hadrontherapy	Foundation IRCCS San Matteo Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	The local progression free survival is measured	The local progression free survival will be assessed at 1-year
Secondary	overall survival	the overall survival of enrolled patients is considered	The overall survival of enrolled patients will be assessed at 2-years
Secondary	resectability rate R0 stratified (operable vs not operable)	how many surgeries completed according to the procedures and with histopathological margins free from the disease/enrolled patients	time of surgery (4-6 weeks after radiotherapy)
Secondary	Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity	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.
Secondary	intra and perioperatory complications	intra and perioperatory complications	The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days