Brachytherapy for Pancreatic Cancer
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves surgery and previous chemotherapy, it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment Directional Brachytherapy Source Implant, CivaSheet, Directional Brachytherapy Source Implant, Planar LDR Source for pancreatic cancer?
The CivaSheet, a novel implantable mesh with directional low-dose radiation sources, has shown promise in improving local control of pancreatic cancer by targeting areas with close or positive surgical margins, which are linked to higher recurrence rates. Early patient outcomes suggest it may help achieve better surgical margins, potentially leading to improved survival rates.12345
Is the CivaSheet safe for use in humans?
How is the CivaSheet treatment different from other treatments for pancreatic cancer?
The CivaSheet is unique because it is an implantable sheet that delivers targeted radiation directly to the surgical margins during surgery, using a matrix of Palladium-103 sources shielded on one side to protect sensitive tissues. This approach helps address the challenge of achieving negative surgical margins, which is crucial for reducing local recurrences and improving survival in pancreatic cancer patients.23789
What is the purpose of this trial?
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.
Research Team
Joshua E. Meyer
Principal Investigator
Fox Chase Cancer Center
Eligibility Criteria
This trial is for adults over 18 with borderline resectable or locally advanced pancreatic cancer who've had specific pre-surgery treatments but no prior radiation in the area. They must be able to undergo anesthesia and surgery (Whipple procedure or distal pancreatectomy), not be pregnant, breastfeeding, or have metastatic disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Implantation
Patients undergo pancreatic cancer resection and receive a CivaSheet LDR directional brachytherapy implant at the time of surgery
Post-operative Monitoring
Patients are monitored for adverse radiation toxicity effects and local cancer recurrence rate
Follow-up
Participants are monitored for safety and effectiveness after treatment, including 2-year survival rates
Treatment Details
Interventions
- Directional Brachytherapy Source Implant
Directional Brachytherapy Source Implant is already approved in United States, European Union for the following indications:
- Pancreatic cancer
- Localized tumors
- Pancreatic cancer
- Localized tumors
- Soft tissue sarcomas
Find a Clinic Near You
Who Is Running the Clinical Trial?
CivaTech Oncology
Lead Sponsor