TriangleNCT01602666 · OUTCOME
Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 3 years
What was measured
Kaplan Meier estimate of the 3-year overall survival (OS) is provided. OS is the time interval measured from enrollment until death from any cause or until last follow-up for those who were alive at the time of analysis. Patients who were lost to follow-up or withdrew consent were censored in this analysis.
Analysis population: Localized NGGCT treated with 30.6 Gy WVF RT + 23.4 Gy primary site boost. Patients must have had complete response (CR) or partial response (PR) to induction chemotherapy by MRI and markers; or underwent second-look surgery and were found to have mature teratoma, residual scar or fibrosis and fit the definition of CR/PR after second-look surgery.
Groups in this outcome
Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)
Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
| Group | Source count |
|---|---|
| Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 66 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT) | 92.42 | Not reported | 82.75 | 96.78 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.75
- upper Limit
- 96.78
- value
- 92.42
- denoms
- counts
- group Id
- OG000
- value
- 66
- units
- Participants
- description
- Kaplan Meier estimate of the 3-year overall survival (OS) is provided. OS is the time interval measured from enrollment until death from any cause or until last follow-up for those who were alive at the time of analysis. Patients who were lost to follow-up or withdrew consent were censored in this analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.
- id
- OG000
- title
- Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)
- param Type
- NUMBER
- population Description
- Localized NGGCT treated with 30.6 Gy WVF RT + 23.4 Gy primary site boost. Patients must have had complete response (CR) or partial response (PR) to induction chemotherapy by MRI and markers; or underwent second-look surgery and were found to have mature teratoma, residual scar or fibrosis and fit the definition of CR/PR after second-look surgery.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice