RECRUITING

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

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Conditions

Pancreatic Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2022-05-06
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05141513

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \> 18 years old
  2. 2. Resectable/BRPC/LAPC as defined by NCCN guidelines (Figure 1) as follows confirmed via CT, EUS, or other imaging modalities.
  3. 3. ECOG performance status 0-2
  4. 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. 5. Candidate for SBRT at JHU
  6. 6. Upfront treatment with multi-agent chemotherapy
  7. 7. Candidate for surgical exploration at JHU
  1. 1. Previous thoracic/abdominal radiation therapy
  2. 2. Unable to receive SBRT at JHU
  3. 3. Duodenal invasion detected on imaging which would exclude candidacy for SBRT
  4. 4. Tumor located in pancreatic body or tail
  5. 5. Unable to undergo Whipple procedure
  6. 6. Evidence of disease not localized to the pancreas
  7. 7. Any arterial reconstruction during surgery
  8. 8. Currently enrolled in another investigational drug or device trial that clinically interferes with this study
  9. 9. Unable to comply with study requirements or follow-up schedule
  10. 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

Contacts and Locations

Study Contact

Amol Narang, MD
CONTACT
410-502-3828
anarang2@jh.edu
Dana B Kaplin, MPH
CONTACT
410-502-3950
dkaplin1@jhmi.edu

Principal Investigator

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

Study Locations (Sites)

Johns Hopkins Hospital
Baltimore, Maryland, 21205
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-06
Study Completion Date2028-04

Study Record Updates

Study Start Date2022-05-06
Study Completion Date2028-04

Terms related to this study

Additional Relevant MeSH Terms

  • Pancreatic Cancer