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

NCT04516135 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2020-0517NCI-2020-05684
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score

  An index value will be calculated for each participant according to page 13 of the user guide. Scores will be summarized using descriptive statistics. Will use a 2-sample t-test to compare the change scores between the single fraction palliative radiation therapy (SFRT) and multi-fraction palliative radiation therapy (MFRT) groups.

  Baseline up to 21 days post-radiation therapy

Secondary Outcomes (8)

• Absolute change in mobility

  Baseline up to 21 days post-radiation therapy

• Absolute change in self-care

  Baseline up to 21 days post-radiation therapy

• Absolute change in activity

  Baseline up to 21 days post-radiation therapy

• Absolute change in pain

  Baseline up to 21 days post-radiation therapy

• Absolute change in anxiety

  Baseline up to 21 days post-radiation therapy

Other Outcomes (4)

• T-cell repertoire

  Up to 1 year

• Vaginal microbiome

  Up to 1 year

• Gut microbiome

  Up to 1 year

Study Arms (2)

Arm A (radiation therapy)

EXPERIMENTAL

Patients undergo standard of care radiation therapy in the form of 3D CRT, IMRT, or VMAT at the physician's discretion for 1 fraction in the absence of disease progression or unacceptable toxicity. Patients with \< 30% decrease in the SIS may receive an additional fraction on day 21 at the physician's discretion.

Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Volume Modulated Arc Therapy

Arm B (radiation therapy)

ACTIVE COMPARATOR

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.

Radiation: 3-Dimensional Conformal Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Volume Modulated Arc Therapy

Interventions

3-Dimensional Conformal Radiation Therapy RADIATION

Undergo 3D CRT

Also known as: 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal

Arm A (radiation therapy); Arm B (radiation therapy)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Arm A (radiation therapy); Arm B (radiation therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (radiation therapy); Arm B (radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Arm A (radiation therapy); Arm B (radiation therapy)

Volume Modulated Arc Therapy RADIATION

Undergo VMAT

Also known as: VMAT

Arm A (radiation therapy); Arm B (radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Cooper Hospital University

Camden, New Jersey, 08103, United States

Location

OhioHealth

Columbus, Ohio, 43215, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Lauren Colbert

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: January 11, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (3)