Status:
RECRUITING
Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Malignant Female Reproductive System Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 affe...
Detailed 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). SE...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04516135
Start Date
January 11 2021
End Date
December 31 2029
Last Update
January 9 2026
Active Locations (3)
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1
Cooper Hospital University
Camden, New Jersey, United States, 08103
2
OhioHealth
Columbus, Ohio, United States, 43215
3
M D Anderson Cancer Center
Houston, Texas, United States, 77030