RecruitingPhase 1Phase 2NCT02843945

Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

Initial Feasibility Study to Evaluate the Safety and Efficacy of the Permanently Implantable LDR CivaSheet® in Combination With External Beam Radiation in the Treatment of Pancreatic Cancer

Sponsor

CivaTech Oncology

Enrollment

80 participants

Start Date

May 31, 2017

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

Summary

Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a small radiation seed placed directly at the tumor site during surgery for pancreatic cancer can help reduce the chance of cancer coming back at the surgical margins after tumor removal. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with borderline resectable or locally advanced pancreatic cancer — cancer that is near the edge of safe surgical removal - You are scheduled for a Whipple procedure or partial pancreatectomy (surgeries to remove pancreatic cancer) - You have already completed chemotherapy and radiation therapy before surgery - The cancer has not spread to other organs - You are able to undergo general anesthesia and are not pregnant or breastfeeding **You may NOT be eligible if...** - The cancer has spread beyond the pancreas to other parts of the body - You have previously had radiation to the same area for a different cancer - Your surgical margins are already clear with no risk of close edges 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

DEVICEDirectional Brachytherapy Source Implant

The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.