RECRUITING

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

Conditions

Metastatic Malignant Female Reproductive System Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Phase II Trial of Palliative Pelvic Radiation Therapy to Improve Health Related Quality of Life in Gynecologic Malignancies

Quick Facts

Study Start:2021-01-11

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04516135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Contact

Lauren Colbert

CONTACT

832-652-6033

lcolbert@mdanderson.org

Principal Investigator

Lauren Colbert

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

Cooper Hospital University

Camden, New Jersey, 08103

United States

OhioHealth

Columbus, Ohio, 43215

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Lauren Colbert, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-11

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-01-11

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Malignant Female Reproductive System Neoplasm