IORT on Borderline Resectable Pancreatic Cancer

NCT ID: NCT04090463

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2027-12-30

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).

Conditions

Borderline Resectable Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IORT group

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

Group Type: EXPERIMENTAL

Intraoperative radiotherapy

Intervention Type: RADIATION

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"

Interventions

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"

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Salvatore Paiella, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Verona, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 24635869 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28069018 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24006012 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29800971 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33593311 (View on PubMed)

Other Identifiers

PancFORT

Identifier Type: -

Identifier Source: org_study_id