Pancreatic CancerPhase 1/2NCT02843945
Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source
A Phase 1/2 study testing Directional Brachytherapy Source Implant in people with Pancreatic Cancer, run by CivaTech Oncology at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Directional Brachytherapy Source Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 May 2017to 30 Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 2 recruiting
- Completed
Rush University Cancer Center
Chicago, Illinois, 60612
- Completed
University Medical Center LSU
New Orleans, Louisiana, 70112
- Recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Colleen Valenti, OCN, 708-684-4694, colleen.valenti@advocatehealth.com
Paul Crossan, MD
- Completed
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Completed
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
- Not yet recruiting
Tampa General Hospital
Tampa, Florida, 33612
Raegen Einsmann, 813-974-7247, reinsmann@usf.edu
Timothy Nywening, MD
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Directional Brachytherapy Source Implant
- Keywords
- brachytherapy, CivaSheet, CivaTech, whipple, radiation, borderline resectable, locally advanced, Pd-103, intraoperative radiation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directional Brachytherapy Source ImplantDevice
The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
| Study group | Role | What they receive |
|---|---|---|
| Directional Brachytherapy Source Implant | Experimental | Patients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects. Receives: Device: Directional Brachytherapy Source Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CivaSheet Radiation Treatement
Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.
Measured: 1 Year
Secondary outcomes (4)
Efficacy of CivaSheet Radiation Treatment
Patients will be monitored for one year to determine the local cancer recurrence rate
Measured: 1 Year
Morbidity of patients following surgery and radiation
2 year survival rates for patients post surgery and CivaSheet radiation treatment
Measured: 2 Year
Post Operative Radiation Dosimetry Calculation
Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory
Measured: 1 Month
Length of Hospital Stay
Length of hospital stay will be monitored to determine if CivaSheet radiation treatment alters the typical length of hospital stay for patients after surgery.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start31 May 2017
- Primary completion29 Oct 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose escalation Phase I followed by a feasibility trial in Phase II
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CivaTech Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joshua Meyer, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843945
- Sponsor's protocol ID
- CT004
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2016
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02843945
- Acronym / sponsor ID
- CT004
- Conditions
- Pancreatic Cancer
- Keywords
- brachytherapy, CivaSheet, CivaTech, whipple, radiation, borderline resectable, locally advanced, Pd-103
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CivaTech OncologyIndustry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation Phase I followed by a feasibility trial in Phase II
| Arm | Type | Receives |
|---|---|---|
| Directional Brachytherapy Source Implant | Experimental | Device: Directional Brachytherapy Source ImplantPatients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- • Subject signed inform consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Directional Brachytherapy Source ImplantThe FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures. | Device | Directional Brachytherapy Source Implant |
Primary outcome
Safety of CivaSheet Radiation Treatement
Time frame: 1 Year
Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.
4 secondary outcomes
Efficacy of CivaSheet Radiation Treatment
Time frame: 1 Year
Morbidity of patients following surgery and radiation
Time frame: 2 Year
Post Operative Radiation Dosimetry Calculation
Time frame: 1 Month
Length of Hospital Stay
Time frame: 1 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Meyer, MD principal investigator
Fox Chase Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Directional Brachytherapy Source Implant in people with Pancreatic Cancer, run by CivaTech Oncology at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carra Castagnero (919-314-5515, ccastagnero@civatechoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CivaSheet Radiation Treatement (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.