IORT on Borderline Resectable Pancreatic Cancer

Borderline Resectable Pancreatic Cancer Clinical Trial

— PancFORT  

Official title:

A Phase II Study of Primary Chemotherapy, Stereotactic Body Radiation Therapy, and Intraoperative Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04090463
• Other study ID #: PancFORT
• Status: Suspended
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: December 30, 2027

Study information

• Verified date: May 2024
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: December 30, 2027
• Est. primary completion date: October 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Borderline Resectable Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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"

Locations

Country	Name	City	State
Italy	General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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 p — View 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. — View 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 I — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-specific survival		36 months
Secondary	Progression-free survival		36 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		36 months
Secondary	Rate of margin-free surgery		30 days
Secondary	Rate of surgical complications		Up to 90 days after surgery
Secondary	Resection rate		Intraoperative