NCT02843945RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 17 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 16 Jun 2016
- Start date
- 31 May 2017
- Primary completion date
- 29 Oct 2027
- Lead sponsor
- CivaTech Oncology
- Diseases
- Pancreatic cancer
- NCT number
- NCT02843945
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 80
- From 31 May 2017 to the primary completion date, 29 Oct 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not surgical candidate
- Recurrent or previously resected tumors
Other illness
- Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
- Documented History of Alcoholism and or drug abuse
Other
- An IRE candidate (IRE is Percutaneous irreversible electroporation)
- Participant in other clinical trials
Who the study is looking for
- • 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rush University Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Completed |
| University Medical Center LSU Coordinator of this site? Confirm its status | New Orleans | United States | Completed |
| Advocate Christ Medical Center Coordinator of this site? Confirm its status | Oak Lawn | United States | Recruiting |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Completed |
| Virginia Commonwealth University/Massey Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Completed |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.