TriangleNCT00499616 · OUTCOME
Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Proportion
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 3 years
What was measured
Descriptive analyses of the proportion of stage 4S infants that experience a surgical or post-operative event.
Analysis population: Eligible and evaluable patients with Stage 4S neuroblastoma that had a biopsy or resection.
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) | 17 |
| Group 3 (Chemotherapy, Surgery) | 19 |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 2 (Chemotherapy, Surgery) | 0.18 | Not reported | 0.06 | 0.41 | Not reported |
| Group 3 (Chemotherapy, Surgery) | 0.11 | Not reported | 0.03 | 0.31 | Not reported |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 0 | Not reported | 0 | 0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.06
- upper Limit
- 0.41
- value
- 0.18
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 0.31
- value
- 0.11
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 7
- units
- Participants
- description
- Descriptive analyses of the proportion of stage 4S infants that experience a surgical or post-operative event.
- 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 and evaluable patients with Stage 4S neuroblastoma that had a biopsy or resection.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Reduced Surgical Morbidity for Patients With Stage 4S Neuroblastoma
- type
- PRIMARY
- unit Of Measure
- Proportion
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice