Single Fraction of Multi-fraction Palliatieve bestralingstherapie ter verbetering van de kwaliteit van leven bij patiënten met gemetastaseerde gynaecologische kankers
Een gerandomiseerde fase II-studie van palliatieve bekkenbestralingstherapie om de gezondheidsgerelateerde kwaliteit van leven bij gynaecologische maligniteiten te verbeteren
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
PRIMARY OBJECTIVE:
I. To determine whether single fraction palliative radiation therapy (SFRT) improves the proportion of patients with improved 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 overall health related quality of life (HR-QOL) over multi fraction palliative radiation therapy (MFRT).
II. To determine whether SFRT improves individual domains of HR-QOL over MFRT.
III. To determine whether SFRT increases clinically meaningful HR-QOL improvement over MFRT.
IV. To determine whether SFRT provides non-inferior symptom burden improvement (SBI) to 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.
V. To describe financial burden of patients undergoing palliative pelvic radiation with SFRT and 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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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New Jersey
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Camden, New Jersey, Verenigde Staten, 08103
- Cooper Hospital University
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Ohio
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Columbus, Ohio, Verenigde Staten, 43215
- OhioHealth
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Texas
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Houston, Texas, Verenigde Staten, 77030
- M D Anderson Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
Ancillary studies
Andere namen:
Ancillary studies Undergo IMRT
Andere namen:
Undergo 3D CRT
Andere namen:
Undergo VMAT
Andere namen:
|
|
Actieve vergelijker: 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. |
Ancillary studies
Andere namen:
Ancillary studies Undergo IMRT
Andere namen:
Undergo 3D CRT
Andere namen:
Undergo VMAT
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score
Tijdsspanne: Baseline up to 21 days post-radiation therapy
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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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Absolute change in mobility
Tijdsspanne: Baseline up to 21 days post-radiation therapy
|
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 self-care
Tijdsspanne: Baseline up to 21 days post-radiation therapy
|
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
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Absolute change in activity
Tijdsspanne: Baseline up to 21 days post-radiation therapy
|
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
Tijdsspanne: Baseline up to 21 days post-radiation therapy
|
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
Tijdsspanne: Baseline up to 21 days post-radiation therapy
|
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
|
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>= 6 point increase in EuroQol-Visual Analogue Scale
Tijdsspanne: Baseline up to 21 days post-radiation therapy
|
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
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|
Decrease in Symptom Inventory (SIS)
Tijdsspanne: At 21 days post-radiation therapy
|
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
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Incidence of adverse events
Tijdsspanne: Within 21 days and up to 1 year
|
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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
T-cell repertoire
Tijdsspanne: Up to 1 year
|
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
Tijdsspanne: 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
|
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Gut microbiome
Tijdsspanne: Up to 1 year
|
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
Tijdsspanne: Up to 21 days
|
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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Lauren Colbert, M.D. Anderson Cancer Center
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2020-0517
- 2020-0517 (Andere identificatie: M D Anderson Cancer Center)
- NCI-2020-05684 (Register-ID: CTRP (Clinical Trial Reporting Program))
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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