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

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ClinicalTrials.gov Identifier: NCT03822936
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Foundation IRCCS San Matteo Hospital
Information provided by (Responsible Party):
Francesca Valvo, CNAO National Center of Oncological Hadrontherapy

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

Condition or disease Intervention/treatment Phase
Cancer of Pancreas Pancreas Adenocarcinoma Resectable Pancreatic Cancer Drug: Preoperative chemotherapy Radiation: Preoperative radiotherapy Phase 2

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment With Chemotherapy and Carbon Ions Radiation Therapy (Hadrontherapy)
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : February 8, 2021
Estimated Study Completion Date : February 8, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Preoperatory chemoradiation therapy with carbon ions
Chemoradiation followed by surgery
Drug: Preoperative chemotherapy
Preoperative chemotherapy, carbon ion therapy, surgery
Other Name: Folinic acid, Irinotecan, fluorouracil, oxaliplatin

Radiation: Preoperative radiotherapy
Preoperative chemotherapy, carbon ion therapy, surgery
Other Name: Carbon ion therapy




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: The local progression free survival will be assessed at 1-year ]
    The local progression free survival is measured


Secondary Outcome Measures :
  1. overall survival [ Time Frame: The overall survival of enrolled patients will be assessed at 2-years ]
    the overall survival of enrolled patients is considered

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822936


Contacts
Contact: Francesca Valvo, MD 0039(0)382078501 ext 409 francesca.valvo@cnao.it
Contact: Direzione medica 0039(0)382078501 direzionemedica@cnao.it

Locations
Italy
CNAO Recruiting
Pavia, Italy, 27100
Contact: Cristina Bono, MSc    +39(0)382078613    cristina.bono@cnao.it   
Sponsors and Collaborators
CNAO National Center of Oncological Hadrontherapy
Foundation IRCCS San Matteo Hospital
Investigators
Principal Investigator: Francesca Valvo, MD CNAO National Center of Oncological Hadrontherapy

Responsible Party: Francesca Valvo, Medical Director, CNAO National Center of Oncological Hadrontherapy
ClinicalTrials.gov Identifier: NCT03822936     History of Changes
Other Study ID Numbers: CNAO 35/2017 C
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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

Keywords provided by Francesca Valvo, CNAO National Center of Oncological Hadrontherapy:
carbon ion radiation therapy
exocrine pancreas
pancreas tumour

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents