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New treatment option for Pancreatic Cancer
Official title Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source
ClinicalTrials.gov ID: NCT02843945
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Oak Lawn, Illinois, United States
- New Orleans, Louisiana, United States
- Philadelphia, Pennsylvania, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Chicago, Illinois, United States; Oak Lawn, Illinois, United States; New Orleans, Louisiana, United States; Philadelphia, Pennsylvania, United States; Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.