To improve overall survival in patients with metastatic cervical cancer by loco-regional therapy with personalized ultra-fractionated radiation
The poor outcomes and local morbidity of disease in metastatic cervical cancer, despite evolution in systemic therapy, argues for novel strategies to improve outcome. Improvements in disease control, prevention of morbid local symptoms and even survival have been demonstrated when treating the primary in other cancer types 3,4 Preliminary retrospective data have associated primary site RT with survival benefit in metastatic cervical cancer, but these did not use standardized RT approaches or consider integration with newer systemic therapies28,29. It thus is hypothesized that primary site RT in cervical cancer may achieve similar improvements, but must balance the specific toxicity risks of this disease site and systemic therapy context. Namely, a successful approach must minimize number of treatments to avoid patient inconvenience and systemic therapy interruption, minimize toxicity, and add potential for enhancing systemic disease control. To do this, this study proposes to use PULSAR, implemented by adaptive MRI-guided SAbR in 5 treatments, to deliver primary site cervical RT with ongoing standard systemic therapy. This approaches minimizes treatment visits, doesn't interrupt systemic therapy, uses response-adapted highly conformal RT with advanced image guidance to minimize toxicity risk, and provides potential for improving efficacy of immunotherapy in those receiving it.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Patients enrolled in this study are planned to receive systemic therapy. Imaging based Ultra-fractionated radiation therapy using a PULSAR technique, which is 5 pulses to gross tumor in pelvis.
UT Southwestern Medical Center
Dallas, Texas, United States
To determine if image guided ultra-fractionated stereotactic adaptive radiotherapy in metastatic/locally recurrent cervical cancer will improve overall survival outcomes
Overall Survival will be assessed as the percent of patients surviving at each time point. Overall survival is defined as time from diagnosis till death.
Time frame: 2 years
To determine the acute and late genitourinary (GU) and gastrointestinal (GI) toxicities
Rates of GU/GI toxicity defined by CTCAE v5 will be measured as acute (≤90 days) and late (\> 90 days) up to 1 year from start of radiotherapy
Time frame: 90 days
To evaluate the local-regional progression after treatment
The rate of local regional recurrence will be defined as disease recurrence in the treated primary tumor and will measured as a time interval from start of radiation treatment to local progression or death, up to 1 year from start of radiotherapy.
Time frame: 1 year
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