TriangleNCT00499616 · OUTCOME
Overall Survival (OS) Rates
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
- 3 years
What was measured
OS time is calculated from date of enrollment until death, or until last contact if the patient is alive.
Analysis population: Eligible intermediate risk patients.
Groups in this outcome
Group 2 (Chemotherapy, Surgery)
2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
Group 3 (Chemotherapy, Surgery)
4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
| Group | Source count |
|---|---|
| Group 2 (Chemotherapy, Surgery) | 175 |
| Group 3 (Chemotherapy, Surgery) | 140 |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 89 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 2 (Chemotherapy, Surgery) | 99.4 | Not reported | 98.3 | 100.0 | Not reported |
| Group 3 (Chemotherapy, Surgery) | 93.5 | Not reported | 89.4 | 97.7 | Not reported |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 88.4 | Not reported | 81.5 | 95.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 98.3
- upper Limit
- 100.0
- value
- 99.4
- group Id
- OG001
- lower Limit
- 89.4
- upper Limit
- 97.7
- value
- 93.5
- group Id
- OG002
- lower Limit
- 81.5
- upper Limit
- 95.3
- value
- 88.4
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 140
- group Id
- OG002
- value
- 89
- units
- Participants
- description
- OS time is calculated from date of enrollment until death, or until last contact if the patient is alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
- id
- OG000
- title
- Group 2 (Chemotherapy, Surgery)
- description
- 4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
- id
- OG001
- title
- Group 3 (Chemotherapy, Surgery)
- description
- 8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
- id
- OG002
- title
- Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
- param Type
- NUMBER
- population Description
- Eligible intermediate risk patients.
- reporting Status
- POSTED
- time Frame
- 3 years
- title
- Overall Survival (OS) Rates
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice