Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer
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.
Arms & 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.
Outcome measures
Primary
Median Progression Free Survival (PFS)
PFS is defined as the time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first
Time frame: 2 years
Secondary
Change in Progression Free Survival (PFS)
Time frame: 1 and 2 years
Median Local Control (LC)
Time frame: 2 years
Change in Local Control (LC)
Time frame: 1 and 2 years
Median Distant Metastasis Free Survival (DMFS)
Time frame: 2 years
Change in Distant Metastasis Free Survival (DMFS)
Time frame: 1 and 2 years
Median Overall Survival (OS)
Time frame: 2 years
Change in Overall Survival (OS)
Time frame: 1 and 2 years
Change in Quality of Life (QOL)
Time frame: Baseline, during radiation therapy, every 3 months for 2 years
Change in Incidence of Grade 3+ Toxicities
Time frame: Baseline, during radiation therapy, every 3 months for 2 years
Location of Recurrence
Time frame: 2 years
Chemotherapy-Free Interval
Time frame: 2 years
Eligibility criteria
Study locations (1)
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
References
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