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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment, the CivaSheet (also known as the Directional Brachytherapy Source Implant), for individuals with pancreatic cancer. The researchers aim to determine if this treatment can safely target residual cancer cells after surgery, reducing the risk of recurrence. The trial seeks participants undergoing surgery to remove pancreatic cancer who have received specific chemotherapy treatments. Eligible participants must not have had previous radiation in the area and should not have cancer that has spread elsewhere. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive this innovative therapy.

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 prior data suggests that the Directional Brachytherapy Source Implant is safe for pancreatic cancer treatment?

Research has shown that the CivaSheet, a type of radiation treatment, is safe for patients. The FDA has approved this implant, confirming it meets safety standards. The CivaSheet directs a low dose of radiation in one direction, targeting cancer cells while protecting healthy tissue.

In past studies, patients tolerated the CivaSheet well, with no significant increases in radiation side effects during surgery. This suggests the treatment is safe, with few negative effects reported. Overall, evidence supports its safety for individuals undergoing pancreatic cancer surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Unlike the standard treatments for pancreatic cancer, which often include surgery followed by external beam radiation therapy and chemotherapy, the Directional Brachytherapy Source Implant is unique because it delivers targeted radiation right at the surgical site. This implant, known as the CivaSheet, is designed to safely increase the radiation dose directly to the area where the tumor was removed, reducing the risk of cancer returning. What makes it especially exciting is its directional capability, which minimizes radiation exposure to surrounding healthy tissues, potentially lowering side effects compared to traditional radiation methods. Researchers are hopeful that this precise delivery method will enhance treatment effectiveness while improving patients' quality of life.

What evidence suggests that the Directional Brachytherapy Source Implant is effective for pancreatic cancer?

Studies have shown that the CivaSheet for targeted radiation therapy can deliver more radiation directly to the surgery area in pancreatic cancer patients. This focused delivery aims to reduce cancer recurrence while minimizing side effects. In this trial, participants undergoing pancreatic cancer resection will receive the CivaSheet implant during surgery. Patients in previous treatments demonstrated better survival rates and fewer cancer recurrences. The FDA has approved the CivaSheet, confirming it meets safety standards, and its special design allows doctors to direct radiation precisely where needed. Early results suggest this method could be a promising option for those undergoing pancreatic cancer surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Joshua E. Meyer

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02843945

NCT02843945 | Initial Feasibility Study to Treat Borderline ... This pilot study may benefit pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to ...

2. americanbrachytherapy.org americanbrachytherapy.org/news-media/abs-news/civasheet-intraoperative-radiation-therapy-for-pancreatic-cancer/

Civasheet Intraoperative Radiation Therapy for Pancreatic ... It is an FDA-cleared implantable matrix of uni-directional planar low-dose-rate (LDR) Palladium-103 (Pd-103) radiation sources encapsulated in an organic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12167782/

Prospective Evaluation of a Novel Unidirectional ... However, implanting standard LDR brachytherapy sources in a surgical bed loses some of the inherent advantage of intraoperative treatment, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S153847212400014X

Brachytherapy Use of LDR brachytherapy at the time of resection shows a trend towards improved progression free and overall survival for patients with borderline or locally ...

5. physicianresources.foxchase.org physicianresources.foxchase.org/news/civasheet-sup/sup-for-precise-radiation-delivery-for-pancreatic-cancer

CivaSheet® for precise radiation delivery for pancreatic ... The directional nature of CivaSheet® allows an increased radiation dose to be delivered safely to the surgical margin, reducing the risk of ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/117149

Initial Feasibility Study to Treat Borderline Resectable ... The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction.