Palliativ strålbehandling med enkel fraktion eller multifraktion för att förbättra livskvaliteten hos patienter med metastaserad gynekologisk cancer
En randomiserad fas II-studie av palliativ bäckenstrålningsterapi för att förbättra hälsorelaterad livskvalitet vid gynekologiska maligniteter
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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
New Jersey
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Camden, New Jersey, Förenta staterna, 08103
- Cooper Hospital University
-
-
Ohio
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Columbus, Ohio, Förenta staterna, 43215
- OhioHealth
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Texas
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Houston, Texas, Förenta staterna, 77030
- M D Anderson Cancer Center
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
Ancillary studies Undergo IMRT
Andra namn:
Undergo 3D CRT
Andra namn:
Undergo VMAT
Andra namn:
|
|
Aktiv komparator: 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
Andra namn:
Ancillary studies Undergo IMRT
Andra namn:
Undergo 3D CRT
Andra namn:
Undergo VMAT
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Absolute change in index value of EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) score
Tidsram: 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. |
Baseline up to 21 days post-radiation therapy
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Absolute change in mobility
Tidsram: 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
Tidsram: 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 activity
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
>= 6 point increase in EuroQol-Visual Analogue Scale
Tidsram: 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
|
|
Decrease in Symptom Inventory (SIS)
Tidsram: 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
|
|
Incidence of adverse events
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
T-cell repertoire
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Lauren Colbert, M.D. Anderson Cancer Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2020-0517
- 2020-0517 (Annan identifierare: M D Anderson Cancer Center)
- NCI-2020-05684 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Läkemedels- och apparatinformation, studiedokument
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