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IORT on Borderline Resectable Pancreatic Cancer (PancFORT)

Primary Purpose

Borderline Resectable Pancreatic Cancer

Status
Suspended
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Intraoperative radiotherapy
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Resectable Pancreatic Cancer focused on measuring Pancreatic cancer, Borderline resectable pancreatic cancer, Intraoperative radiotherapy (IORT), Total neoadjuvant therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IORT group

Arm Description

Intraoperative administration of 10 to 20 Gy after surgery or as an "in situ" treatment in case resection will not be performed

Outcomes

Primary Outcome Measures

Disease-specific survival

Secondary Outcome Measures

Progression-free survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Rate of margin-free surgery
Rate of surgical complications
Resection rate

Full Information

First Posted
September 10, 2019
Last Updated
November 1, 2022
Sponsor
Universita di Verona
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1. Study Identification

Unique Protocol Identification Number
NCT04090463
Brief Title
IORT on Borderline Resectable Pancreatic Cancer
Acronym
PancFORT
Official Title
A Phase II Study of Primary Chemotherapy, Stereotactic Body Radiation Therapy, and Intraoperative Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Logistic and financial reasons
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 30, 2027 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Resectable Pancreatic Cancer
Keywords
Pancreatic cancer, Borderline resectable pancreatic cancer, Intraoperative radiotherapy (IORT), Total neoadjuvant therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IORT group
Arm Type
Experimental
Arm Description
Intraoperative administration of 10 to 20 Gy after surgery or as an "in situ" treatment in case resection will not be performed
Intervention Type
Radiation
Intervention Name(s)
Intraoperative radiotherapy
Intervention Description
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"
Primary Outcome Measure Information:
Title
Disease-specific survival
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
36 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
36 months
Title
Rate of margin-free surgery
Time Frame
30 days
Title
Rate of surgical complications
Time Frame
Up to 90 days after surgery
Title
Resection rate
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital
City
Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24635869
Citation
Palta M, Willett C, Czito B. The role of intraoperative radiation therapy in patients with pancreatic cancer. Semin Radiat Oncol. 2014 Apr;24(2):126-31. doi: 10.1016/j.semradonc.2013.11.004.
Results Reference
result
PubMed Identifier
28069018
Citation
Krempien R, Roeder F. Intraoperative radiation therapy (IORT) in pancreatic cancer. Radiat Oncol. 2017 Jan 10;12(1):8. doi: 10.1186/s13014-016-0753-0.
Results Reference
result
PubMed Identifier
24006012
Citation
Cai S, Hong TS, Goldberg SI, Fernandez-del Castillo C, Thayer SP, Ferrone CR, Ryan DP, Blaszkowsky LS, Kwak EL, Willett CG, Lillemoe KD, Warshaw AL, Wo JY. Updated long-term outcomes and prognostic factors for patients with unresectable locally advanced pancreatic cancer treated with intraoperative radiotherapy at the Massachusetts General Hospital, 1978 to 2010. Cancer. 2013 Dec 1;119(23):4196-204. doi: 10.1002/cncr.28329. Epub 2013 Sep 4.
Results Reference
result
PubMed Identifier
29800971
Citation
Murphy JE, Wo JY, Ryan DP, Jiang W, Yeap BY, Drapek LC, Blaszkowsky LS, Kwak EL, Allen JN, Clark JW, Faris JE, Zhu AX, Goyal L, Lillemoe KD, DeLaney TF, Fernandez-Del Castillo C, Ferrone CR, Hong TS. Total Neoadjuvant Therapy With FOLFIRINOX Followed by Individualized Chemoradiotherapy for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):963-969. doi: 10.1001/jamaoncol.2018.0329. Erratum In: JAMA Oncol. 2018 Oct 1;4(10):1439.
Results Reference
result
PubMed Identifier
33593311
Citation
Paiella S, Malleo G, Simoni N, Micera R, Guariglia S, Cavedon C, Marchegiani G, Esposito A, Landoni L, Casetti L, Tuveri M, Milella M, Secchettin E, Manzini G, Bovo C, De Pastena M, Fontana M, Salvia R, Mazzarotto R, Bassi C. A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma. BMC Cancer. 2021 Feb 16;21(1):165. doi: 10.1186/s12885-021-07877-7.
Results Reference
derived

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IORT on Borderline Resectable Pancreatic Cancer

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