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

NCT04516135 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-02-25

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic Malignant Female Reproductive System Neoplasm

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D CRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Volume Modulated Arc Therapy

Undergo VMAT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lauren Colbert · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04516135 on ClinicalTrials.gov