A Randomized Phase II Trial of Palliative Pelvic Radiation Therapy to Improve Health Related Quality of Life in Gynecologic Malignancies
Overview
- Phase
- Phase 2
- Intervention
- Questionnaire Administration
- Conditions
- Metastatic Malignant Female Reproductive System Neoplasm
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 28
- Locations
- 3
- Primary Endpoint
- Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
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.
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). 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.
Investigators
Eligibility 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
Arms & Interventions
Arm A (radiation therapy)
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.
Intervention: Questionnaire Administration
Arm A (radiation therapy)
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.
Intervention: Quality-of-Life Assessment
Arm A (radiation therapy)
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.
Intervention: 3-Dimensional Conformal Radiation Therapy
Arm A (radiation therapy)
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.
Intervention: Intensity-Modulated Radiation Therapy
Arm A (radiation therapy)
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.
Intervention: Volume Modulated Arc Therapy
Arm B (radiation therapy)
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.
Intervention: 3-Dimensional Conformal Radiation Therapy
Arm B (radiation therapy)
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.
Intervention: Intensity-Modulated Radiation Therapy
Arm B (radiation therapy)
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.
Intervention: Quality-of-Life Assessment
Arm B (radiation therapy)
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.
Intervention: Questionnaire Administration
Arm B (radiation therapy)
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.
Intervention: Volume Modulated Arc Therapy
Outcomes
Primary Outcomes
Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score
Time Frame: Baseline up to 21 days post-radiation therapy
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.
Secondary Outcomes
- 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)
- >= 6 point increase in EuroQol-Visual Analogue Scale(Baseline up to 21 days post-radiation therapy)
- Decrease in Symptom Inventory (SIS)(At 21 days post-radiation therapy)
- Incidence of adverse events(Within 21 days and up to 1 year)
- Absolute change in pain(Baseline up to 21 days post-radiation therapy)
- Absolute change in anxiety(Baseline up to 21 days post-radiation therapy)