Feasibility of a new brachytherapy device for treating borderline resectable pancreatic cancer
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
PHASE1; PHASE2 · CivaTech Oncology · NCT02843945
This study is testing a new device that delivers targeted radiation to help treat pancreatic cancer in patients whose tumors are borderline resectable after they have received chemotherapy and radiation.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CivaTech Oncology (industry) |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 6 sites (Tampa, Florida and 5 other locations) |
| Trial ID | NCT02843945 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a novel brachytherapy device, CivaSheet, designed to deliver unidirectional radiation to pancreatic cancer patients with borderline resectable tumors. The device utilizes Palladium-103 to target diseased tissue while minimizing radiation exposure to surrounding critical structures. The study aims to assess local control rates and determine the optimal method for attaching the device during surgical tumor removal. It involves patients who have undergone neoadjuvant chemoradiation and are selected for surgical procedures like the Whipple or distal pancreatectomy.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with borderline resectable pancreatic adenocarcinoma who are undergoing surgical resection after neoadjuvant chemoradiation.
Not a fit: Patients who are not surgical candidates or have metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve local control of pancreatic cancer and reduce radiation exposure to healthy tissues.
How similar studies have performed: While this approach is novel, similar studies using brachytherapy for cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Subject signed inform consent * Age \> 18 years * Not pregnant or breast feeding * Patient capable of undergoing anesthesia * Patient selected to undergo Whipple procedure or distal pancreatectomy * Patient does not have metastatic disease * Patients will have close margins * No prior radiation therapy to the region for separate cancer * Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma * Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery) * Chemotherapy was administered for 2-6 cycles with any combination of the following agents: * Gemcitabine + nb-paclitaxel * FOLFIRINOX * Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN) * up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil Exclusion Criteria: * Not surgical candidate * Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer * An IRE candidate (IRE is Percutaneous irreversible electroporation) * Recurrent or previously resected tumors * Documented History of Alcoholism and or drug abuse * Participant in other clinical trials
Where this trial is running
Tampa, Florida and 5 other locations
- Tampa General Hospital — Tampa, Florida, United States (NOT_YET_RECRUITING)
- Rush University Cancer Center — Chicago, Illinois, United States (COMPLETED)
- Advocate Christ Medical Center — Oak Lawn, Illinois, United States (RECRUITING)
- University Medical Center LSU — New Orleans, Louisiana, United States (COMPLETED)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (COMPLETED)
- Virginia Commonwealth University Massey Cancer Center — Richmond, Virginia, United States (COMPLETED)
Study contacts
- Principal investigator: Joshua Meyer, MD — Fox Chase Cancer Center
- Study coordinator: Carra Castagnero
- Email: ccastagnero@civatechoncology.com
- Phone: 919-314-5515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Cancer, brachytherapy, CivaSheet, CivaTech, whipple, radiation, borderline resectable, locally advanced