TriangleNCT00085735 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Probability of 3 yr OS rate
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 3 years
What was measured
OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy \[IFRT\]) are combined and compared to arms II, IV and VI (posterior fossa irradiation \[PFRT\]).
Analysis population: Per protocol only eligible \& evaluable pts were included.Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.
Groups in this outcome
Low-dose Craniospinal Radiation (LDSCI)
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
Standard-dose Craniospinal Radiation (SDCSI)
Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
Involved Field Radiation (IFRT)
Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
Posterior Fossa Radiation (PFRT)
Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)
| Group | Source count |
|---|---|
| Low-dose Craniospinal Radiation (LDSCI) | 116 |
| Standard-dose Craniospinal Radiation (SDCSI) | 110 |
| Involved Field Radiation (IFRT) | 227 |
| Posterior Fossa Radiation (PFRT) | 237 |
Reported measurements
IFRT vs PFRT
| Group | Source count |
|---|---|
| Low-dose Craniospinal Radiation (LDSCI) | 0 |
| Standard-dose Craniospinal Radiation (SDCSI) | 0 |
| Involved Field Radiation (IFRT) | 227 |
| Posterior Fossa Radiation (PFRT) | 237 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Involved Field Radiation (IFRT) | 90.3 | Not reported | 86.2 | 94.4 | Not reported |
| Posterior Fossa Radiation (PFRT) | 93.3 | Not reported | 90.0 | 96.6 | Not reported |
LDCSI vs SDCSI
| Group | Source count |
|---|---|
| Low-dose Craniospinal Radiation (LDSCI) | 116 |
| Standard-dose Craniospinal Radiation (SDCSI) | 110 |
| Involved Field Radiation (IFRT) | 0 |
| Posterior Fossa Radiation (PFRT) | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Low-dose Craniospinal Radiation (LDSCI) | 85.5 | Not reported | 78.4 | 92.6 | Not reported |
| Standard-dose Craniospinal Radiation (SDCSI) | 90.4 | Not reported | 84.3 | 96.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG002
- lower Limit
- 86.2
- upper Limit
- 94.4
- value
- 90.3
- group Id
- OG003
- lower Limit
- 90.0
- upper Limit
- 96.6
- value
- 93.3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 227
- group Id
- OG003
- value
- 237
- units
- Participants
- title
- IFRT vs PFRT
- categories
- measurements
- group Id
- OG000
- lower Limit
- 78.4
- upper Limit
- 92.6
- value
- 85.5
- group Id
- OG001
- lower Limit
- 84.3
- upper Limit
- 96.5
- value
- 90.4
- denoms
- counts
- group Id
- OG000
- value
- 116
- group Id
- OG001
- value
- 110
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- LDCSI vs SDCSI
- denoms
- counts
- group Id
- OG000
- value
- 116
- group Id
- OG001
- value
- 110
- group Id
- OG002
- value
- 227
- group Id
- OG003
- value
- 237
- units
- Participants
- description
- OS was defined as the time interval from date of study entry to date of death from any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 3-year estimates are reported with 95% CI's. For purposes of this analysis, arms I, III and V (involved field radiation therapy \[IFRT\]) are combined and compared to arms II, IV and VI (posterior fossa irradiation \[PFRT\]).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
- id
- OG000
- title
- Low-dose Craniospinal Radiation (LDSCI)
- description
- Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
- id
- OG001
- title
- Standard-dose Craniospinal Radiation (SDCSI)
- description
- Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
- id
- OG002
- title
- Involved Field Radiation (IFRT)
- description
- Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)
- id
- OG003
- title
- Posterior Fossa Radiation (PFRT)
- param Type
- NUMBER
- population Description
- Per protocol only eligible \& evaluable pts were included.Pts with anaplastic histology or disseminated/excess residual disease were not evaluable (NE). 26/23 IFRT/PFRT pts were NE, leaving 227 vs 237 for this comparison. The LD/SD CSI comparison was done only in pts 3-7 yrs of age. 11/8 LD/SDCSI pts were NE, leaving 116 vs 110 for this comparison.
- reporting Status
- POSTED
- time Frame
- 3 years
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Probability of 3 yr OS rate
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice