TriangleNCT00302003 · OUTCOME
Intensive Therapy Free Survival (ITFS).
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Probability of survival
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At 60 months
What was measured
Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC\* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.
Analysis population: Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).
Groups in this outcome
Group 1
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
| Group | Source count |
|---|---|
| Group 1 | 275 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 | 0.89 | Not reported | 0.84 | 0.92 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.84
- upper Limit
- 0.92
- value
- 0.89
- denoms
- counts
- group Id
- OG000
- value
- 275
- units
- Participants
- description
- Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC\* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
- id
- OG000
- title
- Group 1
- param Type
- NUMBER
- population Description
- Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).
- reporting Status
- POSTED
- time Frame
- At 60 months
- title
- Intensive Therapy Free Survival (ITFS).
- type
- PRIMARY
- unit Of Measure
- Probability of survival
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice