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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

Must not have

Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer

Recurrent or previously resected tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any cancer except for skin cancer in the last 5 years.

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My tumor has come back or was surgically removed before.

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I am not eligible for surgery.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic radiology procedure

Secondary study objectives

Efficacy of CivaSheet Radiation Treatment

Length of Hospital Stay

Morbidity of patients following surgery and radiation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met