Brachytherapy for Pancreatic Cancer

Recruiting at 1 trial location

Overseen By Kristy Perez

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: CivaTech Oncology

Must be taking: Gemcitabine, FOLFIRINOX

Disqualifiers: Invasive cancer, Alcoholism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

80 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves surgery and previous chemotherapy, it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment Directional Brachytherapy Source Implant, CivaSheet, Directional Brachytherapy Source Implant, Planar LDR Source for pancreatic cancer?

The CivaSheet, a novel implantable mesh with directional low-dose radiation sources, has shown promise in improving local control of pancreatic cancer by targeting areas with close or positive surgical margins, which are linked to higher recurrence rates. Early patient outcomes suggest it may help achieve better surgical margins, potentially leading to improved survival rates. ^{1 2 3 4 5}

Is the CivaSheet safe for use in humans?

The CivaSheet is an FDA-cleared implantable device used in surgeries, designed to protect sensitive areas like the bowel from radiation. It has been used in patients with pancreatic cancer, and early outcomes suggest it is safe for human use. ^{1 2 3 4 6}

How is the CivaSheet treatment different from other treatments for pancreatic cancer?

The CivaSheet is unique because it is an implantable sheet that delivers targeted radiation directly to the surgical margins during surgery, using a matrix of Palladium-103 sources shielded on one side to protect sensitive tissues. This approach helps address the challenge of achieving negative surgical margins, which is crucial for reducing local recurrences and improving survival in pancreatic cancer patients. ^{2 3 7 8 9}

What is the purpose of this trial?

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.

Research Team

Joshua E. Meyer

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

This trial is for adults over 18 with borderline resectable or locally advanced pancreatic cancer who've had specific pre-surgery treatments but no prior radiation in the area. They must be able to undergo anesthesia and surgery (Whipple procedure or distal pancreatectomy), not be pregnant, breastfeeding, or have metastatic disease.

Inclusion Criteria

Subject signed inform consent

Not pregnant or breast feeding

The patient's surgical margins show that the cancer is close to the edge of the removed tissue.

Exclusion Criteria

You have a documented history of alcoholism or drug abuse.

Participant in other clinical trials

My tumor has come back or was surgically removed before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Implantation

Patients undergo pancreatic cancer resection and receive a CivaSheet LDR directional brachytherapy implant at the time of surgery

1 week

1 visit (in-person)

Post-operative Monitoring

Patients are monitored for adverse radiation toxicity effects and local cancer recurrence rate

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 2-year survival rates

2 years

Treatment Details

Interventions

• Directional Brachytherapy Source Implant

Trial Overview The study tests a new method called Directional Brachytherapy Source Implant during surgery for pancreatic cancer. It aims to see how well it works when there's a high risk of cancer left at the edges of where the tumor was removed.

Participant Groups

Group I: Directional Brachytherapy Source Implant Experimental Treatment 1 Intervention

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.

Directional Brachytherapy Source Implant is already approved in United States, European Union for the following indications:

Approved in United States as CivaSheet for:

• Pancreatic cancer
• Localized tumors

Approved in European Union as CivaSheet for:

• Pancreatic cancer
• Localized tumors
• Soft tissue sarcomas

Who Is Running the Clinical Trial?

CivaTech Oncology

Lead Sponsor

Trials

7

Recruited

310+

Findings from Research

The CivaDot brachytherapy source demonstrated excellent repeatability and reproducibility in primary source strength measurements, with less than 1.1% agreement across different measurement methods, indicating reliable performance for clinical use.

Dose distribution measurements showed that the CivaDot's predicted and measured dose rates were closely aligned, with differences generally within 2-3%, suggesting that the CivaDot can deliver precise radiation therapy effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric characterization of a new directional low-dose rate brachytherapy source. Aima, M., DeWerd, LA., Mitch, MG., et al.[2020]

The use of a novel implantable low dose rate (LDR) Pd-103 brachytherapy sheet in 11 patients with resectable or borderline resectable pancreatic cancer showed no procedural complications and added only 15 minutes to surgery time.

At a median follow-up of 13 months, 64% of patients were alive and 55% were disease-free, indicating promising clinical outcomes with minimal toxicity compared to traditional radiation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First report on the feasibility of a permanently implantable uni-directional planar low dose rate brachytherapy sheet for patients with resectable or borderline resectable pancreatic cancer. Dault, JB., Todor, D., Kaplan, BJ., et al.[2021]

The CivaSheet is an FDA-cleared implantable device that uses low-dose-rate Palladium-103 to target areas at risk of cancer recurrence after surgery for borderline resectable pancreatic cancer, potentially improving outcomes by addressing close or positive surgical margins.

This innovative approach allows for customized implantation during surgery, aiming to reduce local recurrences and improve overall survival, although the study also highlights the ongoing challenges in achieving negative margins in pancreatic cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CivaSheet intraoperative radiation therapy for pancreatic cancer. Taylor, RJ., Todor, D., Kaplan, BJ., et al.[2022]

The clinical commissioning of the CivaSheet, a novel 103Pd directional brachytherapy device, successfully established source calibration and validated treatment planning systems, ensuring accurate dose delivery for intraoperative radiation therapy.

Experimental verification showed that the dosimetry parameters were accurate within standard clinical uncertainties, with dose differences remaining within acceptable limits, confirming the device's efficacy for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative implantation of a mesh of directional palladium sources (CivaSheet): Dosimetry verification, clinical commissioning, dose specification, and preliminary experience. Cohen, GN., Episcopia, K., Lim, SB., et al.[2018]

The study demonstrates that a new Pd-103 directional brachytherapy seed can significantly reduce radiation exposure to surrounding sensitive tissues, with doses on the shielded side dropping to less than 4% of the total dose, as shown through Monte Carlo simulations.

This innovative approach aims to improve treatment outcomes by enhancing dose uniformity within the target area while minimizing late skin and subcutaneous toxicities associated with traditional brachytherapy sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SU-E-T-319: Monte Carlo Characterization of a New Directional Pd-103 High Dose Rate Source for Brachytherapy Application. Heredia, A., Robinson, A., Henderson, D., et al.[2019]

The study analyzed the dosimetric impact of the CivaSheet device, which uses directional palladium-103 sources, when implanted on curved surfaces, revealing that curvature significantly affects dose distribution.

Results showed that on inward-facing curved implants, the dose could exceed the prescribed amount by about 20%, while outward-facing implants could lead to a 20% decrease in dose, highlighting the need for careful planning to avoid overdosing healthy tissue or underdosing the tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of a directional palladium-103 brachytherapy device on a curved surface. Veltchev, I., Price, R., Chen, X., et al.[2019]

Intraluminal brachytherapy (ILBT) in the duct of Wirsung for patients with unresectable pancreatic adenocarcinoma was found to be safe, with no endoscopy-related complications and minimal radiation-related toxicity reported.

The treatment showed promising efficacy, with a median survival of 11 months and significant tumor mass reduction in some patients, indicating that ILBT could be a viable option for managing this difficult-to-treat cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of unresectable pancreatic carcinoma by intraluminal brachytherapy in the duct of Wirsung. Mutignani, M., Shah, SK., Morganti, AG., et al.[2004]

Brachytherapy has been utilized for pancreatic cancer for over 80 years, showing effectiveness in achieving local control when combined with external beam radiation and chemotherapy, based on data from around 300 cases.

New techniques like intraluminal and infusional brachytherapy are being developed to reduce the risk of serious complications associated with traditional brachytherapy methods, potentially improving treatment outcomes for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brachytherapy for pancreatic cancer: a review. Dobelbower, RR., Montemaggi, P.[2005]

Intraluminal brachytherapy using 125I seed strands was successfully performed in 18 patients with locally advanced pancreatic ductal adenocarcinoma, achieving a 100% success rate for implantation and effective bile drainage.

The treatment demonstrated acceptable safety with only a few adverse events, and provided a mean overall survival of approximately 11.91 months, suggesting it is a viable option for patients with obstructive jaundice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of intraluminal brachytherapy using 125I seed strand for locally advanced pancreatic ductal adenocarcinoma with obstructive jaundice. Yang, M., Yan, Z., Luo, J., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dosimetric characterization of a new directional low-dose rate brachytherapy source. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

First report on the feasibility of a permanently implantable uni-directional planar low dose rate brachytherapy sheet for patients with resectable or borderline resectable pancreatic cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

CivaSheet intraoperative radiation therapy for pancreatic cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Intraoperative implantation of a mesh of directional palladium sources (CivaSheet): Dosimetry verification, clinical commissioning, dose specification, and preliminary experience. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

SU-E-T-319: Monte Carlo Characterization of a New Directional Pd-103 High Dose Rate Source for Brachytherapy Application. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Application of a directional palladium-103 brachytherapy device on a curved surface. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Treatment of unresectable pancreatic carcinoma by intraluminal brachytherapy in the duct of Wirsung. [2004]

8. Greece pubmed.ncbi.nlm.nih.gov

Brachytherapy for pancreatic cancer: a review. [2005]

9. United States pubmed.ncbi.nlm.nih.gov

A pilot study of intraluminal brachytherapy using 125I seed strand for locally advanced pancreatic ductal adenocarcinoma with obstructive jaundice. [2023]