Comparing single and multiple sessions of radiation therapy for metastatic gynecologic cancers
A Randomized Phase II Trial of Palliative Pelvic Radiation Therapy to Improve Health Related Quality of Life in Gynecologic Malignancies
PHASE2 · M.D. Anderson Cancer Center · NCT04516135
This study is testing if a single session of radiation therapy can improve the quality of life for patients with advanced gynecologic cancers better than the usual multiple sessions.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | Radiation |
| Locations | 3 sites (Camden, New Jersey and 2 other locations) |
| Trial ID | NCT04516135 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates whether a single session of palliative radiation therapy can enhance the quality of life for patients with metastatic gynecologic cancers compared to the standard multiple sessions. The study aims to assess improvements in health-related quality of life (HR-QOL) and symptom burden, while also evaluating the associated toxicity rates and the impact on the immune system. Patients will be randomized to receive either single fraction or multi-fraction radiation therapy, with various methods of radiation delivery employed. Additionally, the study will explore the effects on the vaginal and gut microbiomes and the financial burden of treatment.
Who should consider this trial
Good fit: Ideal candidates include females with documented metastatic gynecologic cancers experiencing pelvic disease-related symptoms.
Not a fit: Patients who have previously received pelvic radiation therapy or those currently undergoing systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and less burdensome treatment option for patients suffering from metastatic gynecologic cancers.
How similar studies have performed: Other studies have shown promise in using single fraction radiation therapy for palliative care, suggesting potential benefits in quality of life improvements.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Camden, New Jersey and 2 other locations
- Cooper Hospital University — Camden, New Jersey, United States (ACTIVE_NOT_RECRUITING)
- OhioHealth — Columbus, Ohio, United States (RECRUITING)
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Lauren Colbert — M.D. Anderson Cancer Center
- Study coordinator: Lauren Colbert
- Email: lcolbert@mdanderson.org
- Phone: 832-652-6033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Malignant Female Reproductive System Neoplasm