TriangleNCT01096368 · OUTCOME
EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
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
- Up to 10 years after enrollment. 5-year estimates of EFS are presented.
What was measured
Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval.
Analysis population: Eligible, randomized participants (intent-to-treat) in stratum 2 (completely resected ependymom at initial surgery)
Groups in this outcome
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 2
Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma with incomplete resection after initial surgery and then CR after induction chemotherapy, or patients with GTR/NTR after second surgery (stratum 2) are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy.
Arm III: Randomized to Radiation Only in Stratum 2
Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) with incomplete resection after initial surgery and then CR after induction chemotherapy, or patients with GTR/NTR after second surgery (stratum 2) are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation.
| Group | Source count |
|---|---|
| Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 2 | 20 |
| Arm III: Randomized to Radiation Only in Stratum 2 | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 2 | 41.7 | Not reported | 17.9 | 64.0 | Not reported |
| Arm III: Randomized to Radiation Only in Stratum 2 | 67.5 | Not reported | 41.4 | 84.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.004
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.175
- estimate Comment
- Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.
- group Description
- In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.041
- p Value Comment
- P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.
- param Type
- Hazard Ratio (HR)
- param Value
- 2.684
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 1.004
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.175
- estimate Comment
- Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.
- group Description
- In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.041
- p Value Comment
- P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.
- param Type
- Hazard Ratio (HR)
- param Value
- 2.684
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.9
- upper Limit
- 64.0
- value
- 41.7
- group Id
- OG001
- lower Limit
- 41.4
- upper Limit
- 84.0
- value
- 67.5
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 19
- units
- Participants
- description
- Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma with incomplete resection after initial surgery and then CR after induction chemotherapy, or patients with GTR/NTR after second surgery (stratum 2) are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy.
- id
- OG000
- title
- Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 2
- description
- Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) with incomplete resection after initial surgery and then CR after induction chemotherapy, or patients with GTR/NTR after second surgery (stratum 2) are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation.
- id
- OG001
- title
- Arm III: Randomized to Radiation Only in Stratum 2
- param Type
- NUMBER
- population Description
- Eligible, randomized participants (intent-to-treat) in stratum 2 (completely resected ependymom at initial surgery)
- reporting Status
- POSTED
- time Frame
- Up to 10 years after enrollment. 5-year estimates of EFS are presented.
- title
- EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice