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

Description

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).

Conditions

Pancreatic Cancer

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Pancreatic Cancer
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,

Amol Narang, MD, PRINCIPAL_INVESTIGATOR, JHU, School of Medicine, SKCCC

Study Record Dates

2028-04