Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers

Running, not enrolling · Phase 2

Conditions studied: Metastatic Malignant Female Reproductive System Neoplasm

In brief

This phase II trial studies if a single session of palliative radiation therapy can help improve symptoms of gynecologic cancers that have spread to other places in the body (metastatic) and that affect quality of life as well or more so than multiple sessions (which is the standard of care). Palliative radiation therapy may help patients with metastatic gynecologic cancers live more comfortably. Researchers also want to learn how radiation affects the immune system and to compare the effects of giving one radiation treatment to giving multiple radiation treatments.

Key facts

Study ID

NCT04516135

Run by

M.D. Anderson Cancer Center

People needed

28

Starts

2021-01-11

Expected to finish

2029-12-31

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically documented gynecologic cancer with prior or current evidence of metastatic disease
• Measurable pelvic disease with any pain and/or bleeding
• Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
• Estimated life expectancy > 3 months at discretion of treating physician
• Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
• Patient able to provide properly obtained written informed consent
• Gynecologic Section Radiation Oncology Quality Assurance (QA) for eligibility for single fraction radiation treatment

You may not qualify if…

• Prior pelvic radiation therapy that would make treatment unsafe at the discretion of the treating physician
• Systemic therapy concurrently or within 21 days of first dose of radiation
• Concurrent participation in another interventional radiation therapy trial concurrently or within 30 days of study consent. Note: Patients who are participating in systemic clinical trials and non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation
• Known second malignancy that requires active treatment (at the discretion of the primary investigator)
• Documented psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• Pregnant or breastfeeding at any point starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment

Where it is running

• Cooper Hospital University — Camden, New Jersey, United States
• OhioHealth — Columbus, Ohio, United States
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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