IORT on Borderline Resectable Pancreatic Cancer

NCT04090463 | Suspended Phase 2

• 1 other identifier: PancFORT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Borderline Resectable Pancreatic Cancer

Keywords

Pancreatic cancer; Borderline resectable pancreatic cancer; Intraoperative radiotherapy (IORT); Total neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Disease-specific survival

  36 months

Secondary Outcomes (5)

• Progression-free survival

  36 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  36 months

• Rate of margin-free surgery

  30 days

• Rate of surgical complications

  Up to 90 days after surgery

• Resection rate

  Intraoperative

Study Arms (1)

IORT group

EXPERIMENTAL

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

Interventions

Intraoperative radiotherapy 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"

IORT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

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

Verona, 37134, Italy

Location

Related Publications (5)

• 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.

  PMID: 24635869 RESULT

• 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.

  PMID: 28069018 RESULT

• 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.

  PMID: 24006012 RESULT

• 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.

  PMID: 29800971 RESULT

• 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.

  PMID: 33593311 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 16, 2019
• Study Start: October 1, 2019
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)