Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Baptist Health South Florida
- Study ID
- NCT05679674
- Status
- Recruiting
Conditions
- Locally Advanced
- Locally Advanced Pancreatic Adenocarcinoma
- Pancreas Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Stereotactic Ablative Body Radiation (SABR) — RADIATION50 Gy in 5 fractions, once per day for 5 days
- Tumor Treating Fields (TTF) — DEVICEParticipant 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.
Study Details
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.
Key Dates
- Start date
- Sep 21, 2023
- Status verified
- Jan 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF)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
Primary Outcome Measure
Median Progression Free Survival (PFS) [ Time Frame: 2 years ]
Central Contacts
- Michael Chuong, M.D.(786) 596-2000
- Carla Salazar(786) 595-7073
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 |
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