TriangleNCT00750269 · OUTCOME
Local Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
What was measured
Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
Analysis population: All eligible patients who started study treatment
Groups in this outcome
Level 5: 10.0 Gy/FX
SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
Level 6: 10.5 Gy/FX
SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
Level 7: 11.0 Gy/FX
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
Level 8: 11.5 Gy/FX
SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
Level 9: 12.0 Gy/FX
SBRT 60.0 Gy SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy
| Group | Source count |
|---|---|
| Level 5: 10.0 Gy/FX | 8 |
| Level 6: 10.5 Gy/FX | 7 |
| Level 7: 11.0 Gy/FX | 14 |
| Level 8: 11.5 Gy/FX | 38 |
| Level 9: 12.0 Gy/FX | 33 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Level 5: 10.0 Gy/FX | 12.5 | Not reported | 0.5 | 44.5 | Not reported |
| Level 6: 10.5 Gy/FX | 0 | Not reported | NA | NA | A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events. |
| Level 7: 11.0 Gy/FX | 14.3 | Not reported | 2.1 | 37.7 | Not reported |
| Level 8: 11.5 Gy/FX | 10.6 | Not reported | 3.3 | 22.9 | Not reported |
| Level 9: 12.0 Gy/FX | 12.3 | Not reported | 3.8 | 26.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 44.5
- value
- 12.5
- comment
- A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG002
- lower Limit
- 2.1
- upper Limit
- 37.7
- value
- 14.3
- group Id
- OG003
- lower Limit
- 3.3
- upper Limit
- 22.9
- value
- 10.6
- group Id
- OG004
- lower Limit
- 3.8
- upper Limit
- 26.1
- value
- 12.3
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 38
- group Id
- OG004
- value
- 33
- units
- Participants
- description
- Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
- id
- OG000
- title
- Level 5: 10.0 Gy/FX
- description
- SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
- id
- OG001
- title
- Level 6: 10.5 Gy/FX
- description
- SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
- id
- OG002
- title
- Level 7: 11.0 Gy/FX
- description
- SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
- id
- OG003
- title
- Level 8: 11.5 Gy/FX
- description
- SBRT 60.0 Gy SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy
- id
- OG004
- title
- Level 9: 12.0 Gy/FX
- param Type
- NUMBER
- population Description
- All eligible patients who started study treatment
- reporting Status
- POSTED
- time Frame
- From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
- title
- Local Progression
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice