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Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma (PIOPPO)

Primary Purpose

Cancer of Pancreas, Pancreas Adenocarcinoma, Resectable Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Preoperative chemotherapy

Preoperative radiotherapy

About this trial

This is an interventional treatment trial for Cancer of Pancreas focused on measuring carbon ion radiation therapy, exocrine pancreas, pancreas tumour

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CNAORecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preoperatory chemoradiation therapy with carbon ions

Arm Description

Chemoradiation followed by surgery

Outcomes

Primary Outcome Measures

Progression free survival

The local progression free survival is measured

Secondary Outcome Measures

overall survival

the overall survival of enrolled patients is considered

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

Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity

intra and perioperatory complications

Full Information

NCT ID

NCT03822936

First Posted

January 25, 2019

Last Updated

August 31, 2021

Sponsor

CNAO National Center of Oncological Hadrontherapy

Collaborators

Foundation IRCCS San Matteo Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03822936

Brief Title

Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

Acronym

PIOPPO

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 8, 2018 (Actual)

Primary Completion Date

February 8, 2023 (Anticipated)

Study Completion Date

February 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

CNAO National Center of Oncological Hadrontherapy

Collaborators

Foundation IRCCS San Matteo Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of Pancreas, Pancreas Adenocarcinoma, Resectable Pancreatic Cancer

Keywords

carbon ion radiation therapy, exocrine pancreas, pancreas tumour

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Preoperatory chemoradiation therapy with carbon ions

Arm Type

Experimental

Arm Description

Chemoradiation followed by surgery

Intervention Type

Drug

Intervention Name(s)

Preoperative chemotherapy

Other Intervention Name(s)

Folinic acid, Irinotecan, fluorouracil, oxaliplatin

Intervention Description

Preoperative chemotherapy, carbon ion therapy, surgery

Intervention Type

Radiation

Intervention Name(s)

Preoperative radiotherapy

Other Intervention Name(s)

Carbon ion therapy

Intervention Description

Preoperative chemotherapy, carbon ion therapy, surgery

Primary Outcome Measure Information:

Title

Progression free survival

Description

The local progression free survival is measured

Time Frame

The local progression free survival will be assessed at 1-year

Secondary Outcome Measure Information:

Title

overall survival

Description

the overall survival of enrolled patients is considered

Time Frame

The overall survival of enrolled patients will be assessed at 2-years

Title

resectability rate R0 stratified (operable vs not operable)

Description

how many surgeries completed according to the procedures and with histopathological margins free from the disease/enrolled patients

Time Frame

time of surgery (4-6 weeks after radiotherapy)

Title

Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity

Description

Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity

Time Frame

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.

Title

intra and perioperatory complications

Description

intra and perioperatory complications

Time Frame

The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francesca Valvo, MD

Phone

0039(0)382078501

Ext

612

francesca.valvo@cnao.it

First Name & Middle Initial & Last Name or Official Title & Degree

Direzione medica

Phone

0039(0)382078501

direzionemedica@cnao.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francesca Valvo, MD

Organizational Affiliation

CNAO National Center of Oncological Hadrontherapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

CNAO

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cristina Bono, MSc

Phone

+39(0)382078613

cristina.bono@cnao.it

12. IPD Sharing Statement

Citations:

PubMed Identifier

31521134

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.

Results Reference

derived

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Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

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