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

August 31, 2021 updated by: Francesca Valvo, CNAO National Center of Oncological Hadrontherapy

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Pavia, Italy, 27100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperatory chemoradiation therapy with carbon ions
Chemoradiation followed by surgery
Drug: Preoperative chemotherapy
Preoperative chemotherapy, carbon ion therapy, surgery
Other Names:
  • Folinic acid, Irinotecan, fluorouracil, oxaliplatin
Radiation: Preoperative radiotherapy
Preoperative chemotherapy, carbon ion therapy, surgery
Other Names:
  • Carbon ion therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: The local progression free survival will be assessed at 1-year
The local progression free survival is measured
The local progression free survival will be assessed at 1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: The overall survival of enrolled patients will be assessed at 2-years
the overall survival of enrolled patients is considered
The overall survival of enrolled patients will be assessed at 2-years
resectability rate R0 stratified (operable vs not operable)
Time Frame: 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
time of surgery (4-6 weeks after radiotherapy)
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.
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
Time Frame: The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days
intra and perioperatory complications
The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CNAO National Center of Oncological Hadrontherapy

Collaborators

Foundation IRCCS San Matteo Hospital

Investigators

  • Principal Investigator: Francesca Valvo, MD, CNAO National Center of Oncological Hadrontherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2018

Primary Completion (Anticipated)

February 8, 2023

Study Completion (Anticipated)

February 8, 2023

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNAO 35/2017 C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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