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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
50 Gy in 5 fractions, once per day for 5 days
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.
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
RECRUITINGMedian 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
Change in 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: 1 and 2 years
Median Local Control (LC)
LC is defined as a response within the radiation target volume according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (i.e., percentage of participants with stable disease, partial response, or complete response).
Time frame: 2 years
Change in Local Control (LC)
LC is defined as a response within the radiation target volume according to RECIST) v1.1 criteria (i.e., percentage of participants with stable disease, partial response, or complete response).
Time frame: 1 and 2 years
Median Distant Metastasis Free Survival (DMFS)
DMFS is defined as the time from initiation of study therapy to the first radiographic confirmation of distant metastasis
Time frame: 2 years
Change in Distant Metastasis Free Survival (DMFS)
DMFS is defined as the time from initiation of study therapy to the first radiographic confirmation of distant metastasis
Time frame: 1 and 2 years
Median Overall Survival (OS)
OS is defined as the time from the initiation of study therapy to death due to any cause or date of last follow-up, whichever occurs first.
Time frame: 2 years
Change in Overall Survival (OS)
OS is defined as the time from the initiation of study therapy to death due to any cause or date of last follow-up, whichever occurs first.
Time frame: 1 and 2 years
Change in Quality of Life (QOL)
Quality of Life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire designed to measure four domains of QOL in cancer patients: physical, social, emotional, and functional well-being. Each domain has a scoring range of 0-28, for a combined total score of 0-108, where higher scores indicate better QOL.
Time frame: Baseline, during radiation therapy, every 3 months for 2 years
Change in Incidence of Grade 3+ Toxicities
All participants will be evaluable for toxicity from the time of their first treatment. All Grade 3+ toxicities \[according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0\] will be tracked, regardless of attribution to study treatment.
Time frame: Baseline, during radiation therapy, every 3 months for 2 years
Location of Recurrence
Location of recurrence is defined as the site(s) at the time of any first tumor recurrence: local only \[centroid of the recurrence within the planning target volume (PTV)\], distant only (centroid of the recurrence outside of the PTV), or local and distant.
Time frame: 2 years
Chemotherapy-Free Interval
The chemotherapy-free interval is defined as the duration of time from the initiation of study therapy to the date any chemotherapy is subsequently administered.
Time frame: 2 years
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