Clinical trialPhase 1 / Phase 2Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 31 May 2017
- Expected end
- 30 October 2028
- Enrollment
- 80 participants
- Sites
- 6
- Primary outcomes
- Safety of CivaSheet Radiation Treatement
- Sponsor
- Industry
- Results posted
- No
- Last update
- 17 June 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.