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

Last updated: May 13, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Questionnaire Administration

Volume Modulated Arc Therapy

Quality-of-Life Assessment

Clinical Study ID

NCT04516135
2020-0517
2020-0517
NCI-2020-05684
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically documented gynecologic cancer with prior or currentevidence 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 adequatemethod of contraception for the course of the study through 120 days after the lastdose of study medication

  • Patient able to provide properly obtained written informed consent

  • Gynecologic Section Radiation Oncology Quality Assurance (QA) for eligibility forsingle fraction radiation treatment

Exclusion

Exclusion Criteria:

  • Prior pelvic radiation therapy that would make treatment unsafe at the discretion ofthe treating physician

  • Systemic therapy concurrently or within 21 days of first dose of radiation

  • Concurrent participation in another interventional radiation therapy trialconcurrently or within 30 days of study consent. Note: Patients who areparticipating 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 theprimary investigator)

  • Documented psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the trial

  • Pregnant or breastfeeding at any point starting with the pre-screening or screeningvisit through 120 days after the last dose of trial treatment

Study Design

Total Participants: 108
Treatment Group(s): 5
Primary Treatment: Questionnaire Administration
Phase: 2
Study Start date:
January 11, 2021
Estimated Completion Date:
December 31, 2025

Study Description

PRIMARY OBJECTIVE:

I. To determine whether single fraction palliative radiation therapy (SFRT) improves health-related quality of life (HR-QOL) over multi-fraction palliative radiotherapy (MFRT).

SECONDARY OBJECTIVES:

I. To determine whether single fraction palliative radiation therapy (SFRT) improves individual domains of health-related quality of life (HR-QOL) over multi-fraction palliative radiotherapy (MFRT).

II. To determine whether SFRT increases clinically meaningful HR-QOL improvement over MFRT.

III. To determine whether SFRT provides non-inferior symptom burden improvement to MFRT.

IV. To describe radiation related toxicity rates within 21 days and within year for patients receiving SFRT and MFRT.

EXPLORATORY OBJECTIVES:

I. To describe T-cell repertoire of patients receiving SFRT and MFRT. II. To describe vaginal microbiome of patients receiving SFRT and MFRT. III. To describe gut microbiome of patients receiving SFRT and MFRT. IV. To describe financial burden of patients undergoing palliative pelvic radiation with either SFRT or MFRT.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo standard of care radiation therapy in the form of 3-dimensional conformal radiation therapy (3D CRT), intensity-modulated radiation therapy (IMRT), or volume modulated arc therapy (VMAT) at the physician's discretion for 1 fraction in the absence of disease progression or unacceptable toxicity. Patients with < 30% decrease in the Symptom Inventory Scale (SIS) may receive an additional fraction on day 21 at the physician's discretion.

ARM B: Patients undergo standard of care radiation therapy in the form of 3D CRT, IMRT, or VMAT at the physician's discretion over 2 weeks for 10 fractions in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Connect with a study center

  • Cooper Hospital University

    Camden, New Jersey 08103
    United States

    Site Not Available

  • OhioHealth

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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