TriangleNCT00087438 · OUTCOME
Local Control at 2 Years
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of subjects
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the start of treatment to 2 years
What was measured
Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method.
Analysis population: Eligible patients who started protocol treatment.
Groups in this outcome
Stereotactic Body Radiation Therapy (SBRT)
20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
| Group | Source count |
|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | 97.6 | Not reported | 84.3 | 99.7 | Not reported |
Source statistical analyses
- group Description
- Null hypothesis = 60% two-year local control (0.02128/mo. hazard rate); alternative = 80% (0.0093/mo.) assuming at least approximately exponential distribution of time to local progression. Using the asymptotic properties of the ratio of the logarithms of hazard rates, less than 18 cases of local progression were required for a Type I error rate of 0.05 with 80% power to detect a difference in local control rates at least this large. Hazard rate estimated using life table two-year estimates.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.013
- p Value Comment
- Test statistic = \[ln(estimated hazard rate) - ln(hypothesized hazard rates)\] / \[1/square root (number of patients with local progression by two years\]. Reject null hypothesis at an alpha level of 0.05 if test statistics is less than -1.645.
- statistical Method
- z-test, one-sided
Complete source fields
- analyses
- group Description
- Null hypothesis = 60% two-year local control (0.02128/mo. hazard rate); alternative = 80% (0.0093/mo.) assuming at least approximately exponential distribution of time to local progression. Using the asymptotic properties of the ratio of the logarithms of hazard rates, less than 18 cases of local progression were required for a Type I error rate of 0.05 with 80% power to detect a difference in local control rates at least this large. Hazard rate estimated using life table two-year estimates.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.013
- p Value Comment
- Test statistic = \[ln(estimated hazard rate) - ln(hypothesized hazard rates)\] / \[1/square root (number of patients with local progression by two years\]. Reject null hypothesis at an alpha level of 0.05 if test statistics is less than -1.645.
- statistical Method
- z-test, one-sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 84.3
- upper Limit
- 99.7
- value
- 97.6
- denoms
- counts
- group Id
- OG000
- value
- 55
- units
- Participants
- description
- Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
- id
- OG000
- title
- Stereotactic Body Radiation Therapy (SBRT)
- param Type
- NUMBER
- population Description
- Eligible patients who started protocol treatment.
- reporting Status
- POSTED
- time Frame
- From the start of treatment to 2 years
- title
- Local Control at 2 Years
- type
- PRIMARY
- unit Of Measure
- percentage of subjects
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice