Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy for Metastatic Cervical Cancer

Phase 2

Active, not recruiting

• Conditions: Metastasis; Adenosquamous Carcinoma of Cervix; Cervical Cancer; Stage IV Cervical Cancer FIGO 2018

• Registration Number: NCT05021237
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

To improve overall survival in patients with metastatic cervical cancer by loco-regional therapy with personalized ultra-fractionated radiation

Detailed Description

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 Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-25
• Study Start: 2022-02-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-21
• Last Update Posted: 2025-08-28
• Primary Completion: 2028-08
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine if image guided ultra-fractionated stereotactic adaptive radiotherapy in metastatic/locally recurrent cervical cancer will improve overall survival outcomes	2 years	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.

Secondary Outcome Measures

Name	Time	Method
To determine the acute and late genitourinary (GU) and gastrointestinal (GI) toxicities	90 days	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
To evaluate the local-regional progression after treatment	1 year	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.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States