TriangleNCT00499616 · OUTCOME
Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of 3 yr EFS survival
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 10 years
What was measured
To test the predictive ability of the extent of surgical resection for EFS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection.
Analysis population: Eligible and evaluable intermediate risk patients with reported surgery
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) | 174 |
| Group 3 (Chemotherapy, Surgery) | 137 |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 81 |
Reported measurements
EFS w/complete surgical resection
| Group | Source count |
|---|---|
| Group 2 (Chemotherapy, Surgery) | 65 |
| Group 3 (Chemotherapy, Surgery) | 43 |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 28 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 2 (Chemotherapy, Surgery) | 95.4 | Not reported | 90.0 | 100.0 | Not reported |
| Group 3 (Chemotherapy, Surgery) | 88.4 | Not reported | 78.7 | 98.1 | Not reported |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 78.6 | Not reported | 63.4 | 93.8 | Not reported |
EFS w/o complete surgical resection
| Group | Source count |
|---|---|
| Group 2 (Chemotherapy, Surgery) | 109 |
| Group 3 (Chemotherapy, Surgery) | 94 |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 53 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 2 (Chemotherapy, Surgery) | 82.2 | Not reported | 74.6 | 89.8 | Not reported |
| Group 3 (Chemotherapy, Surgery) | 85.1 | Not reported | 77.7 | 92.4 | Not reported |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | 69.2 | Not reported | 56.3 | 82.1 | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- The event-free survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- OTHER
- p Value
- .0253
- param Type
- Log-Rank Test Statistic
- param Value
- 5.0049
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- The event-free survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- OTHER
- p Value
- .0253
- param Type
- Log-Rank Test Statistic
- param Value
- 5.0049
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 90.0
- upper Limit
- 100.0
- value
- 95.4
- group Id
- OG001
- lower Limit
- 78.7
- upper Limit
- 98.1
- value
- 88.4
- group Id
- OG002
- lower Limit
- 63.4
- upper Limit
- 93.8
- value
- 78.6
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 28
- units
- Participants
- title
- EFS w/complete surgical resection
- categories
- measurements
- group Id
- OG000
- lower Limit
- 74.6
- upper Limit
- 89.8
- value
- 82.2
- group Id
- OG001
- lower Limit
- 77.7
- upper Limit
- 92.4
- value
- 85.1
- group Id
- OG002
- lower Limit
- 56.3
- upper Limit
- 82.1
- value
- 69.2
- denoms
- counts
- group Id
- OG000
- value
- 109
- group Id
- OG001
- value
- 94
- group Id
- OG002
- value
- 53
- units
- Participants
- title
- EFS w/o complete surgical resection
- denoms
- counts
- group Id
- OG000
- value
- 174
- group Id
- OG001
- value
- 137
- group Id
- OG002
- value
- 81
- units
- Participants
- description
- To test the predictive ability of the extent of surgical resection for EFS, log-rank tests will be performed comparing complete surgical resection vs. without complete surgical resection.
- 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 intermediate risk patients with reported surgery
- reporting Status
- POSTED
- time Frame
- Up to 10 years
- title
- Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Event Free Survival (EFS)
- type
- PRIMARY
- unit Of Measure
- percentage of 3 yr EFS survival
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Preserved source evidence · Not medical advice