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IORT on Borderline Resectable Pancreatic Cancer (PancFORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04090463
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : April 9, 2020
Information provided by (Responsible Party):
Salvatore Paiella, MD, Universita di Verona

Brief Summary:
This phase II study investigates the efficacy of IORT for patients with borderline resectable pancreatic cancer. The purpose of the study is to investigate whether the addition of IORT, after FOLOFIRINOX-base chemotherapy, and SBRT, increases the 3-year survival rate. A total of 101 patients will be enrolled, and these patients will receive IORT of 10 to 20 Gy, according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).

Condition or disease Intervention/treatment Phase
Borderline Resectable Pancreatic Cancer Radiation: Intraoperative radiotherapy Phase 2

Detailed Description:

Treatment outcomes of borderline resectable pancreatic cancer are still poor even after completion of FOLFIRINOX-based chemotherapy and radical resection. A growing body of literature is demonstrating that Stereotactic body radiation therapy (SBRT) and Intraoperative radiotherapy (IORT), within a multimodal approach, allow to obtain better oncological outcome, at the price of low to negligible rates of morbidity and mortality. The investigators hypothesize that a "total neoadjuvant" scenario, with the best current therapy, based on up to 6 months of FOLFIRINOX (minimum 4), SBRT and IORT (in situ or after surgery) would increase the disease-specific survival of borderline resectable pancreatic cancer patients. An historical cohort will be used as a comparison group.

Considering the intention-to-treat design and the institutional rates of chemotherapy completion and exploration/resection of borderline resection pancreatic cancer patients, a total of 100 patients will be enrolled in this phase II trial. Patients submitted to IORT, will receive IORT of 10 to 20 Gy according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Primary Chemotherapy, Stereotactic Body Radiation Therapy, and Intraoperative Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 30, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IORT group
Intraoperative administration of 10 to 20 Gy after surgery or as an "in situ" treatment in case resection will not be performed
Radiation: Intraoperative radiotherapy

IORT will be delivered as follows:

  1. Radical resection --> delivery of 10-15 Gy to the tumor bed
  2. Non radical resection --> delivery of 15-20 Gy to the tumor "in situ"

Primary Outcome Measures :
  1. Disease-specific survival [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 36 months ]
  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 36 months ]
  3. Rate of margin-free surgery [ Time Frame: 30 days ]
  4. Rate of surgical complications [ Time Frame: Up to 90 days after surgery ]
  5. Resection rate [ Time Frame: Intraoperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • • Biopsy-proven, previously untreated borderline resectable PC, defined according to the NCCN guidelines v1.2019;

    • Age 18-80 years;
    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
    • Adequate bone marrow function (absolute neutrophil count ≥1500 per cubic millimeter; platelet count ≥100.000 per cubic millimeter; hemoglobin level ≥10 g per deciliter), liver function (serum total bilirubin level ≤1.5 times the upper limit of the normal range), and renal function (creatinine clearance ≥50 ml per minute);
    • Ability to understand the characteristics of the clinical trial;
    • Written informed consent.

Exclusion Criteria:

  • • Ampullary, biliary, or duodenal adenocarcinoma; pancreatic adenocarcinoma in the background of an intraductal papillary mucinous neoplasia (IPMN), other uncommon pancreatic adenocarcinomas (acinar-cell, squamous, giant-cell osteoclastic-like);

    • Invasive cancer in the last 5 years requiring radiation therapy to the upper abdomen or chemotherapy;
    • Symptomatic heart failure or coronary artery disease;
    • Pregnant or lactating women;
    • Impaired mental state or language problems.

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 identifier (NCT number): NCT04090463

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Contact: Giuseppe Malleo, MD, PhD 00458126516
Contact: Salvatore Paiella, MD, PhD 00390458126009

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General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital Recruiting
Verona, Italy, 37134
Contact: Erica Secchettin, PharmD    00390458126254   
Sponsors and Collaborators
Universita di Verona
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Salvatore Paiella, MD, Principal Investigator, Universita di Verona Identifier: NCT04090463    
Other Study ID Numbers: PancFORT
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salvatore Paiella, MD, Universita di Verona:
Pancreatic cancer
Borderline resectable pancreatic cancer
Intraoperative radiotherapy (IORT)
Total neoadjuvant therapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases