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Radiation Therapy

SABR + TTF for Pancreatic Cancer

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years
Awards & highlights

Study Summary

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

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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Progression Free Survival (PFS)
Secondary outcome measures
Change in Distant Metastasis Free Survival (DMFS)
Change in Incidence of Grade 3+ Toxicities
Change in Local Control (LC)
+8 more

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

Find a Location

Who is running the clinical trial?

Michael ChuongLead Sponsor
NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,684 Total Patients Enrolled
Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,783 Total Patients Enrolled

Media Library

Stereotactic Ablative Body Radiation (SABR) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05679674 — N/A
Pancreatic Cancer Research Study Groups: Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF)
Pancreatic Cancer Clinical Trial 2023: Stereotactic Ablative Body Radiation (SABR) Highlights & Side Effects. Trial Name: NCT05679674 — N/A
Stereotactic Ablative Body Radiation (SABR) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05679674 — N/A

Frequently Asked Questions

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

Is this research actively seeking participants?

"A glance at clinicaltrials.gov reveals that this medical study, which was first introduced on January 1st 2023 and last updated late December 2022, is no longer seeking patients for enrollment. Despite this particular trial closing its doors to recruitment, there are 690 other studies actively recruiting participants currently."

Answered by AI
~32 spots leftby Jun 2027