RecruitingPhase 1NCT05141513

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

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


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

25 participants

Start Date

May 6, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of radiation therapy approaches — including targeted radiation during surgery — for people with pancreatic cancer that may be removable, borderline removable, or locally advanced. Researchers want to see if adding intraoperative radiation (radiation given directly during surgery) after standard pre-surgery treatment improves outcomes. **You may be eligible if...** - You are over 18 years old - You have pancreatic cancer (specifically in the head of the pancreas) confirmed by imaging - You are in reasonably good health (able to carry out daily activities) - You are being treated at Johns Hopkins and are a candidate for stereotactic body radiation therapy (SBRT) and possible surgery - You have started or plan to start multi-drug chemotherapy first **You may NOT be eligible if...** - You have had prior radiation to the chest or abdomen - Your tumor has spread beyond the pancreas - Your tumor is in the body or tail of the pancreas (not the head) - You cannot undergo the Whipple surgical procedure - You are pregnant or trying to become pregnant - You are already in another drug or device trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHigh 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(1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

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NCT05141513


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