TriangleNCT00027846 · OUTCOME
Event-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Probability of EFS at 5 years
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5 years after completion of study treatment
What was measured
Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.
Analysis population: The product-limit (Kaplan-Meier) estimate is for estimation of event-free survival probability at 5 years. All eligible patients in the study were included.
Groups in this outcome
GTR1 Differentiated Histology Supratentorial (Group 1)
Patients undergo observation.
Radiation (Group 2)
Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks
Sub-Total Resection Any Histology or Location (STR) (Group 3)
Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
| Group | Source count |
|---|---|
| GTR1 Differentiated Histology Supratentorial (Group 1) | 11 |
| Radiation (Group 2) | 281 |
| Sub-Total Resection Any Histology or Location (STR) (Group 3) | 64 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GTR1 Differentiated Histology Supratentorial (Group 1) | 0.614 | Not reported | 0.33 | 0.90 | Not reported |
| Radiation (Group 2) | 0.685 | Not reported | 0.63 | 0.74 | Not reported |
| Sub-Total Resection Any Histology or Location (STR) (Group 3) | 0.372 | Not reported | 0.25 | 0.50 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.33
- upper Limit
- 0.90
- value
- 0.614
- group Id
- OG001
- lower Limit
- 0.63
- upper Limit
- 0.74
- value
- 0.685
- group Id
- OG002
- lower Limit
- 0.25
- upper Limit
- 0.50
- value
- 0.372
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 281
- group Id
- OG002
- value
- 64
- units
- Participants
- description
- Event-free survival is calculated from the date of study enrollment to the date of disease progression, disease relapse, occurrence of second neoplasm, or death from any cause. The product-limit (Kaplan-Meier) estimate is for estimation of Event -free survival (EFS) probability at 5 years.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients undergo observation.
- id
- OG000
- title
- GTR1 Differentiated Histology Supratentorial (Group 1)
- description
- Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks. radiation therapy: Given once daily 5 days a week for 6-6½ weeks
- id
- OG001
- title
- Radiation (Group 2)
- description
- Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy. filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC \>1500/μl given subcutaneously or intravenously. carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient
- id
- OG002
- title
- Sub-Total Resection Any Histology or Location (STR) (Group 3)
- param Type
- NUMBER
- population Description
- The product-limit (Kaplan-Meier) estimate is for estimation of event-free survival probability at 5 years. All eligible patients in the study were included.
- reporting Status
- POSTED
- time Frame
- Up to 5 years after completion of study treatment
- title
- Event-free Survival
- type
- PRIMARY
- unit Of Measure
- Probability of EFS at 5 years
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice