TriangleNCT00750269 · OUTCOME
(Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)
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
- 90% Confidence Interval
- Time frame
- From start of SBRT to 2 years.
What was measured
Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting 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. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.
Analysis population: All eligible patients who started study treatment
Groups in this outcome
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 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 8: 11.5 Gy/FX | 89.4 | Not reported | 81.6 | 97.4 | Not reported |
| Level 9: 12.0 Gy/FX | 87.7 | Not reported | 78.3 | 97 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 81.6
- upper Limit
- 97.4
- value
- 89.4
- group Id
- OG001
- lower Limit
- 78.3
- upper Limit
- 97
- value
- 87.7
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 33
- units
- Participants
- description
- Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting 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. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.
- dispersion Type
- 90% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- 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 start of SBRT to 2 years.
- title
- (Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice