RecruitingNot ApplicableNCT05679674

Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer

Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer


Sponsor

Baptist Health South Florida

Enrollment

48 participants

Start Date

Sep 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this clinical trial is to determine whether using chemotherapy followed by stereotactic ablative body radiation therapy (SABR) and tumor treating fields (TTF) will slow tumor growth in people with locally advanced pancreas cancer. All participants will receive SABR therapy once per day for five days and use the TTF system for at least 18 hours per day starting on the first day of SABR until the tumor progresses or severe toxicity develops.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two treatments for locally advanced pancreatic cancer — a precise form of radiation called SBRT combined with a wearable electric field device (Tumor Treating Fields) — for patients whose cancer has not spread but cannot be surgically removed. **You may be eligible if...** - You have been confirmed to have locally advanced pancreatic cancer (adenocarcinoma) - You have received at least 3 months of chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) without your cancer spreading further - Your cancer marker (CA 19-9) is not extremely elevated - You are in good enough health (ECOG 0–1) and your organ function is adequate - You are able to wear and operate the electric field device independently or with help **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have had prior abdominal radiation - You have inflammatory bowel disease (Crohn's or colitis) - You have a pacemaker or other electrical implant in your torso - You are pregnant or breastfeeding - You are allergic to the adhesive pads used with the electric field device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Ablative Body Radiation (SABR)

50 Gy in 5 fractions, once per day for 5 days

DEVICETumor Treating Fields (TTF)

Participant will use the system for at least 18 hours per day starting on the first day of SABR until abdominal disease progression. Short treatment breaks are permitted for personal needs (such as to take a shower) and during radiation therapy. An additional treatment break is permitted for up to 48 hours every 21 days.


Locations(1)

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States

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NCT05679674


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