Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
Primary Purpose
Pancreas Cancer, Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CivaSheet
Sponsored by
About this trial
This is an interventional treatment trial for Pancreas Cancer focused on measuring Whipple, brachytherapy, CivaSheet, CivaTech Oncology, radiation, intraoperative radiation, IORT, resectable pancreatic cancer, Pd-103
Eligibility Criteria
Inclusion Criteria:
- Subject signed informed consent
- Age >/= 18 years
- Biopsy confirmed adenocarcinoma pancreatic cancer
- Patient capable of undergoing anesthesia
- Patient is a surgical candidate
- Patient selected to undergo pancreatic cancer resection
- Patient will have known or suspected close/positive surgical margin
- Confirmed diagnosis of resectable pancreatic adenocarcinoma
- Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle
Exclusion Criteria:
- Pregnant or breast feeding
- Patient has metastatic disease
- Patient has had prior radiation therapy to the region for separate cancer
- Patient has had prior chemotherapy
- Any other invasive cancer in the past 5 years, except basal cell skin
- Recurrent or previously resected tumors
- Alcoholism/Drug abuse
Sites / Locations
- East Carolina University, Brody School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Directional Brachytherapy Source Implant
Arm Description
Patients undergoing a whipple procedure for pancreatic cancer will receive an implant at the time of surgery of the new CivaSheet directional brachytherapy device. 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.
Outcomes
Primary Outcome Measures
Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale
Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety & toxicities graded using the CTCAE 4.0 scale.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03109041
Brief Title
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
Official Title
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CivaTech Oncology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Cancer
Keywords
Whipple, brachytherapy, CivaSheet, CivaTech Oncology, radiation, intraoperative radiation, IORT, resectable pancreatic cancer, Pd-103
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Directional Brachytherapy Source Implant
Arm Type
Experimental
Arm Description
Patients undergoing a whipple procedure for pancreatic cancer will receive an implant at the time of surgery of the new CivaSheet directional brachytherapy device. 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.
Intervention Type
Device
Intervention Name(s)
CivaSheet
Intervention Description
The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiation 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.
Primary Outcome Measure Information:
Title
Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale
Description
Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety & toxicities graded using the CTCAE 4.0 scale.
Time Frame
1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject signed informed consent
Age >/= 18 years
Biopsy confirmed adenocarcinoma pancreatic cancer
Patient capable of undergoing anesthesia
Patient is a surgical candidate
Patient selected to undergo pancreatic cancer resection
Patient will have known or suspected close/positive surgical margin
Confirmed diagnosis of resectable pancreatic adenocarcinoma
Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle
Exclusion Criteria:
Pregnant or breast feeding
Patient has metastatic disease
Patient has had prior radiation therapy to the region for separate cancer
Patient has had prior chemotherapy
Any other invasive cancer in the past 5 years, except basal cell skin
Recurrent or previously resected tumors
Alcoholism/Drug abuse
Facility Information:
Facility Name
East Carolina University, Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
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