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Radiation Therapy

SABR + TTF for Pancreatic Cancer

Miami, FL

N/A

Recruiting

Led By Michael Chuong, M.D.

Research Sponsored by Michael Chuong

Eligibility Criteria Checklist

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

Must have

Able to operate the tumor treating field (NovoTTF-100L) system independently or with assistance

At least 4 months of prior FOLFIRINOX or modified FOLFIRINOX delivered for pancreas cancer without evidence of distant progression on restaging radiographic studies

Must not have

History of significant uncontrolled cardiovascular disease

Distant metastasis from pancreas cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if chemo and a combination of SABR and TTF therapy can slow tumor growth in locally advanced pancreas cancer.

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Who is the study for?

This trial is for adults with advanced pancreatic cancer who've had specific chemotherapy for at least 4 months without the cancer spreading. They must have good organ function, not be pregnant or breastfeeding, and can't have a history of certain diseases or electrical implants in their torso. Participants need to agree to use contraception and be able to operate or get help operating the TTF device.Check my eligibility

What is being tested?

The study tests if chemotherapy followed by Stereotactic Ablative Body Radiation (SABR) therapy once daily for five days plus continuous Tumor Treating Fields (TTF) therapy can slow tumor growth in locally advanced pancreas cancer patients.See study design

What are the potential side effects?

Potential side effects include skin irritation from adhesives or hydrogel used with TTF, fatigue from radiation, possible organ inflammation due to SABR, and general discomfort from carrying the TTF device.

Eligibility Criteria

Inclusion Criteria

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

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I can use the NovoTTF-100L system by myself or with help.

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I've had FOLFIRINOX treatment for pancreatic cancer without the cancer spreading.

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My pancreatic cancer is advanced but hasn't spread far, according to NCCN guidelines.

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My blood counts and liver function tests are within normal ranges.

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I am fully active or can carry out light work.

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Exclusion Criteria

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

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I have a history of serious heart disease that is not under control.

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My pancreatic cancer has spread to distant parts of my body.

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I have had radiation therapy to my abdomen before.

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I don't have lasting side effects from cancer treatment above mild.

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I have a heart rhythm problem that needs treatment or causes symptoms.

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I have a history of inflammatory bowel disease.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Median Progression Free Survival (PFS)

Secondary study objectives

Change in Distant Metastasis Free Survival (DMFS)

Change in Incidence of Grade 3+ Toxicities

Change in Local Control (LC)

+8 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: Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF)Experimental Treatment2 Interventions

50 Gy in five fractions SABR (once per day for 5 days) and use of the TTF system for 18 hours per day starting on the first day of SABR and continuing until abdominal disease progression

0 / 11Eligibility criteria met