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PancFORT: IORT on Borderline Resectable Pancreatic Cancer

Sponsor
Universita di Verona (Other)
Overall Status
Recruiting
CT.gov ID
NCT04090463
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
99
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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).

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2019
Anticipated Primary Completion Date :
Oct 30, 2027
Anticipated Study Completion Date :
Dec 30, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Disease-specific survival [36 months]

Secondary Outcome Measures

  1. Progression-free survival [36 months]

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [36 months]

  3. Rate of margin-free surgery [30 days]

  4. Rate of surgical complications [Up to 90 days after surgery]

  5. Resection rate [Intraoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital Verona Italy 37134

Sponsors and Collaborators

  • Universita di Verona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Salvatore Paiella, MD, Principal Investigator, Universita di Verona
ClinicalTrials.gov Identifier:
NCT04090463
Other Study ID Numbers:
  • PancFORT
First Posted:
Sep 16, 2019
Last Update Posted:
May 13, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Salvatore Paiella, MD, Principal Investigator, Universita di Verona
Pancreatic cancer
Borderline resectable pancreatic cancer
Intraoperative radiotherapy (IORT)
Total neoadjuvant therapy
Additional relevant MeSH terms:
Pancreatic Neoplasms

Study Results

No Results Posted as of May 13, 2021