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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-05684 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0517 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-Dimensional Conformal Radiation Therapy | Radiation | Undergo 3D CRT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in mobility | Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension. | Baseline up to 21 days post-radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| T-cell repertoire | Will describe T-cell clonality, diversity, clonal overlap, productive and nonproductive frequencies using descriptive statistics. Informal comparisons may be completed to generate hypotheses for future studies. | Up to 1 year |
| Vaginal microbiome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Colbert | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper Hospital University | Camden | New Jersey | 08103 | United States | ||
| OhioHealth |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Intensity-Modulated Radiation Therapy | Radiation | Undergo IMRT |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Volume Modulated Arc Therapy | Radiation | Undergo VMAT |
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| Absolute change in self-care | Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension. | Baseline up to 21 days post-radiation therapy |
| Absolute change in activity | Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension. | Baseline up to 21 days post-radiation therapy |
| Absolute change in pain | Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension. | Baseline up to 21 days post-radiation therapy |
| Absolute change in anxiety | Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension. | Baseline up to 21 days post-radiation therapy |
| >= 6 point increase in EuroQol-Visual Analogue Scale | Will summarize the number of patients with clinical meaningful health-related (HR)-quality of life (QOL) improvement using frequencies and proportions. The proportion of patients with clinically meaningful HR-QOL improvement will be compared between SFRT and MFRT using a chi-squared test. | Baseline up to 21 days post-radiation therapy |
| Decrease in Symptom Inventory (SIS) | Will be calculated as the average of the worst pain, least pain, pain on average, pain right now and scores from the vaginal bleeding questions. The change in SIS score from baseline to 21 days post radiation therapy will be calculated for each patient and evaluated between the SFRT and MFRT groups using a t-test. Will be calculated as the average of the worst pain, least pain, pain on average, pain right now and scores from the vaginal bleeding questions. The change in SIS score from baseline to 21 days post radiation therapy will be calculated for each patient and evaluated between the SFRT and MFRT groups using a t-test. | At 21 days post-radiation therapy |
| Incidence of adverse events | Assessed per Common Terminology Criteria for Adverse Events version 5.0. Radiation related toxicity event rates within 21 days and within one year for patients receiving SFRT and MFRT will be summarized using frequencies and proportions. Proportions between SFRT and MFRT will be compared using a chi-squared or Fisher's exact test. | Within 21 days and up to 1 year |
Will use alpha and beta diversity metrics for both 16S and whole-genome sequencing (WGS), including overall diversity, richness and evenness and species-specific microbial dynamics. Will be summarized using descriptive statistics. Informal comparisons may be completed to generate hypotheses for future studies. |
| Up to 1 year |
| Gut microbiome | Will use alpha and beta diversity metrics for both 16S and WGS sequencing, including overall diversity, richness and evenness and species-specific microbial dynamics. Will be summarized using descriptive statistics. Informal comparisons may be completed to generate hypotheses for future studies. | Up to 1 year |
| Financial burden | Will be assessed using the Economic Strain and Resilience in Cancer Financial Toxicity Questionnaire. The scores for each question will be summarized using descriptive statistics. An overall average score will be calculated by calculating the mean score of the seven questions. At the end of the questionnaire, the patient is asked to rate their overall financial situation as much better, better, nearly the same, worse, or much worse. The frequency of each answer to the global question will be tabulated. | Up to 21 days |
| Columbus |
| Ohio |
| 43215 |
| United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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