TriangleNCT03548285 · OUTCOME
Health-related Quality of Life Following Treatment With SABR.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Full Range
- Time frame
- From baseline to 2 years post-treatment
What was measured
Average patient visual analogue scale score (derived from EQ-5D) at baseline, 6, 12, and 24 months from the end of treatment The Visual Analogue Score (VAS) of the EQ-5D is a visual scale from 0-100, with 100 being perfect health, where patients can mark their perceived health. Researchers can then take the average score across all patients for each timepoint.
Groups in this outcome
Patients Receiving SBRT Treatment
Radiation therapy: Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT) Early-stage larynx cancer patients; all patients received SBRT (study treatment) at one of two different dose levels based on cohort (determined by whether the patient was low or moderate risk). The treatment fields are identical in both cohorts, and are expected to have the same patterns-of-failure. The dosing of these patients is not experimental and therefore was not a factor in analysis: all patients were analyzed together, as all received the same experimental treatment (SBRT). The biologically effective dose of this regimen is identical according to EQD2 (equivalent dose in 2 Gray fractions) analysis; in 5 fractions, the dose was equivalent to 65.52 Gy, and in 16 fractions, the dose was equivalent to 65.28 Gy. Therefore the biological impact of both regimens was the same, and this equivalence is why we analyzed the AE's together. The only potential difference between these dosing regimens is in late effects (1 year and after), but we saw no grade 2 or higher adverse events in either cohort, eliminating the need to report out late adverse events separately.
| Group | Source count |
|---|---|
| Patients Receiving SBRT Treatment | 25 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Patients Receiving SBRT Treatment | 78 | Not reported | 0 | 100 | Not reported |
6 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Patients Receiving SBRT Treatment | 86.2 | Not reported | 0 | 100 | Not reported |
12 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Patients Receiving SBRT Treatment | 83.2 | Not reported | 0 | 100 | Not reported |
24 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Patients Receiving SBRT Treatment | 85.5 | Not reported | 0 | 100 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 100
- value
- 78
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 100
- value
- 86.2
- title
- 6 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 100
- value
- 83.2
- title
- 12 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 100
- value
- 85.5
- title
- 24 Months
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- Average patient visual analogue scale score (derived from EQ-5D) at baseline, 6, 12, and 24 months from the end of treatment The Visual Analogue Score (VAS) of the EQ-5D is a visual scale from 0-100, with 100 being perfect health, where patients can mark their perceived health. Researchers can then take the average score across all patients for each timepoint.
- dispersion Type
- Full Range
- groups
- description
- Radiation therapy: Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT) Early-stage larynx cancer patients; all patients received SBRT (study treatment) at one of two different dose levels based on cohort (determined by whether the patient was low or moderate risk). The treatment fields are identical in both cohorts, and are expected to have the same patterns-of-failure. The dosing of these patients is not experimental and therefore was not a factor in analysis: all patients were analyzed together, as all received the same experimental treatment (SBRT). The biologically effective dose of this regimen is identical according to EQD2 (equivalent dose in 2 Gray fractions) analysis; in 5 fractions, the dose was equivalent to 65.52 Gy, and in 16 fractions, the dose was equivalent to 65.28 Gy. Therefore the biological impact of both regimens was the same, and this equivalence is why we analyzed the AE's together. The only potential difference between these dosing regimens is in late effects (1 year and after), but we saw no grade 2 or higher adverse events in either cohort, eliminating the need to report out late adverse events separately.
- id
- OG000
- title
- Patients Receiving SBRT Treatment
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- From baseline to 2 years post-treatment
- title
- Health-related Quality of Life Following Treatment With SABR.
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice