Intraoperative Radiation Therapy After Stereotactic Body Radiation Therapy and Chemotherapy in Treatment of Pancreatic Adenocarcinoma

Pancreatic Cancer Clinical Trial

Official title:

A Safety Study of Intraoperative Radiation Therapy Following Stereotactic Body Radiation Therapy and Multi-agent Chemotherapy in the Treatment of Localized Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05141513
• Other study ID #: J21105
• Secondary ID: IRB00294801
• Status: Recruiting
• Phase: Phase 1
• Start date: May 6, 2022
• Est. completion date: April 2028

Study information

• Verified date: February 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Amol Narang, MD
• Phone: 410-502-3828
• Email: anarang2[@]jh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate the safety of intraoperative radiation therapy (IORT) in patients with localized pancreatic cancer undergoing surgical resection after neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT).

Description:

Standard of care treatment for patients with non-metastatic pancreatic adenocarcinoma (PDAC) includes chemotherapy and Stereotactic Body Radiation Treatment (SBRT) followed by surgical resection of the tumor with or without Intra-Operative Radiation Therapy (IORT). There is some evidence from other research studies suggesting that adding radiation treatment during the surgical resection may improve local control of the cancer. The use of IORT plus surgical resection can be used to treat pancreatic cancer and is done on a case by case basis at Johns Hopkins. The department of Radiation Oncology has developed a program using a High Dose Rate-IORT (HDR-IORT). The HDR-IORT makes it possible to deliver concentrated radiation dose at the surface of the tumor. Our team has shown in previous studies that the majority of cancer cells that remain after treatment are located around the area of the pancreas called the "Triangle Volume" (TV). This region contains blood vessels, lymphatic vessels, and nerves, and is at high risk of containing cancer cells. This region is difficult to treat with SBRT alone because of being close to normal, healthy organs. Therefore, this study involves using IORT to treat the TV to a therapeutic radiation dose. The part of the treatment that is considered research is: - Giving one dose of 15 Gy during the surgery using IORT to deliver radiation, and - Targeting the larger area around the pancreas called the TV The goal of this study is to determine safety of this added treatment which will be assessed at 3 months after the surgery is completed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 2028
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years old

2. Resectable/BRPC/LAPC as defined by NCCN guidelines (Figure 1) as follows confirmed via CT, EUS, or other imaging modalities.

3. ECOG performance status 0-2

4. Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.

5. Candidate for SBRT at JHU

6. Upfront treatment with multi-agent chemotherapy

7. Candidate for surgical exploration at JHU

Exclusion Criteria:

1. Previous thoracic/abdominal radiation therapy

2. Unable to receive SBRT at JHU

3. Duodenal invasion detected on imaging which would exclude candidacy for SBRT

4. Tumor located in pancreatic body or tail

5. Unable to undergo Whipple procedure

6. Evidence of disease not localized to the pancreas

7. Any arterial reconstruction during surgery

8. Currently enrolled in another investigational drug or device trial that clinically interferes with this study

9. Unable to comply with study requirements or follow-up schedule

10. Women of child bearing potential or sexually active fertile men with partners who are women of child bearing potenital who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer

Intervention

Radiation:
• High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT)
After the patient receives standard of care treatment, they will receive a single dose of radiation (15 Gy) at the time the tumor is surgically removed. Surgeons will then place clips along the blood vessels around the surgical area. These clips will be used to confirm (after surgery) that the expected dose of radiation was received during surgery.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute post-operative toxicity of targeted IORT	To evaluate acute post-operative toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.	3 months
Secondary	Late post-operative toxicity of targeted IORT	To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.; To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.	6 months
Secondary	Late post-operative toxicity of targeted IORT	To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.; To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.	12 months
Secondary	Late post-operative toxicity of targeted IORT	To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.; To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.	24 months
Secondary	Late post-operative toxicity of targeted IORT	To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.; To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.	36 months
Secondary	Median local-progression free survival (LPFS) from IORT	To determine the median local-progression free survival (LPFS) from time of IORT.	6 months
Secondary	Median local-progression free survival (LPFS) from IORT	To determine the median local-progression free survival (LPFS) from time of IORT.	12 months
Secondary	Median local-progression free survival (LPFS) from IORT	To determine the median local-progression free survival (LPFS) from time of IORT.	24 months
Secondary	Median local-progression free survival (LPFS) from IORT	To determine the median local-progression free survival (LPFS) from time of IORT.	36 months
Secondary	Median overall survival (OS) from IORT	To determine the median overall survival (OS) from time of IORT.	6 months
Secondary	Median overall survival (OS) from IORT	To determine the median overall survival (OS) from time of IORT.	12 months
Secondary	Median overall survival (OS) from IORT	To determine the median overall survival (OS) from time of IORT.	24 months
Secondary	Median overall survival (OS) from IORT	To determine the median overall survival (OS) from time of IORT.	36 months
Secondary	Median progression free survival (PFS) from IORT	To determine the median progression free survival (PFS) from time of IORT	6 months
Secondary	Median progression free survival (PFS) from IORT	To determine the median progression free survival (PFS) from time of IORT	12 months
Secondary	Median progression free survival (PFS) from IORT	To determine the median progression free survival (PFS) from time of IORT	24 months
Secondary	Median progression free survival (PFS) from IORT	To determine the median progression free survival (PFS) from time of IORT	36 months