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Brachytherapy

Brachytherapy for Pancreatic Cancer

Phase 1 & 2

Recruiting

Led By Joshua Meyer, MD

Research Sponsored by CivaTech Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Chemotherapy was administered for 2-6 cycles with any combination of the following agents: Gemcitabine + nb-paclitaxel, FOLFIRINOX

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

Study Summary

This trial is evaluating the best way to attach a medical device called the CivaSheet in order to improve local control of cancerous tumors.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed, brachytherapy can generally cause pain, swelling at the implant site, infection risk, bleeding, and potential damage to nearby organs or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I received 2-6 rounds of chemotherapy with Gemcitabine and/or FOLFIRINOX.

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I received specific radiation and chemotherapy before surgery for my cancer.

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I am scheduled for a Whipple procedure or distal pancreatectomy.

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My diagnosis is advanced pancreatic cancer that might be operable.

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My cancer has not spread to other parts of my body.

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I can safely undergo anesthesia.

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I have not had radiation therapy on the area for a different cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Therapeutic radiology procedure

Secondary outcome measures

Efficacy of CivaSheet Radiation Treatment

Length of Hospital Stay

Morbidity of patients following surgery and radiation

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Directional Brachytherapy Source ImplantExperimental Treatment1 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.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

CivaTech OncologyLead Sponsor

6 Previous Clinical Trials

226 Total Patients Enrolled

Joshua Meyer, MDPrincipal InvestigatorFox Chase Cancer Center

6 Previous Clinical Trials

143 Total Patients Enrolled

Media Library

Directional Brachytherapy Source Implant (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02843945 — Phase 1 & 2

Pancreatic Cancer Research Study Groups: Directional Brachytherapy Source Implant

Pancreatic Cancer Clinical Trial 2023: Directional Brachytherapy Source Implant Highlights & Side Effects. Trial Name: NCT02843945 — Phase 1 & 2

Directional Brachytherapy Source Implant (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02843945 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical investigation being conducted in multiple healthcare facilities within Canada?

"At the time of writing, 5 medical centres are actively recruiting participants for this trial. Within these locations you can find Oak Lawn, Chicago and New Orleans as well as an additional 2 sites. To make sure travel requirements stay low, it is advised to select a site in close proximity to yourself if enrollment occurs."

Answered by AI

How many participants are presently taking part in the experiment?

"To complete this study, 80 qualified patients must be enrolled. The sponsor of the trial, CivaTech Oncology, will execute it via established medical centres such as Advocate Christ Medical Center in Oak Lawn and Rush University Cancer Centre in Chicago."

Answered by AI

Is this trial actively searching for participants?

"Affirmative. Clinicaltrials.gov hosts a record that shows this medical study, which was initially posted on May 31st 2017 is currently recruiting volunteers. 80 participants need to be sourced from 5 separate sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source

2017. "Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02843945.