TriangleNCT00499616 · OUTCOME
Image Defined Risk Factor (IDRF)
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
- Not reported
- Time frame
- At baseline
What was measured
Percentage of patients with presence of one or more IDRFs will be calculated. IDRFs describe anatomic features which may make surgical resection more difficult.
Analysis population: All eligible and evaluable patients enrolled on ANBL0531
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) | 141 |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 88 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 2 (Chemotherapy, Surgery) | 54.86 | Not reported | Not reported | Not reported | Not reported |
| Group 3 (Chemotherapy, Surgery) | 60.28 | Not reported | Not reported | Not reported | Not reported |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 56.82 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 54.86
- group Id
- OG001
- value
- 60.28
- group Id
- OG002
- value
- 56.82
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 141
- group Id
- OG002
- value
- 88
- units
- Participants
- description
- Percentage of patients with presence of one or more IDRFs will be calculated. IDRFs describe anatomic features which may make surgical resection more difficult.
- 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
- All eligible and evaluable patients enrolled on ANBL0531
- reporting Status
- POSTED
- time Frame
- At baseline
- title
- Image Defined Risk Factor (IDRF)
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice