TriangleNCT00499616 · OUTCOME
Correlation Between Extent of Surgical Resection With the Maintenance of Local Control, Surgical Complication Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Proportion with surgical complications
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 10 years
What was measured
To test for the association of the extent of surgical resection (CR vs \<CR) with surgical complications rate (complications of any kind vs no complications at all), a chi-square test will be performed.
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
CR with complications
| 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) | .32 | Not reported | .22 | .44 | Not reported |
| Group 3 (Chemotherapy, Surgery) | .19 | Not reported | .10 | .33 | Not reported |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | .18 | Not reported | .08 | .36 | Not reported |
CR with no complications
| 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) | .14 | Not reported | .09 | .21 | Not reported |
| Group 3 (Chemotherapy, Surgery) | .13 | Not reported | .07 | .21 | Not reported |
| Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy) | .09 | Not reported | .04 | .20 | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- The association between extent of surgical resection with occurrence of complications was determined using the chi-square test.
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- OTHER
- p Value
- .0016
- param Type
- Chi-Square Test Statistic
- param Value
- 9.9111
- statistical Method
- Chi-squared
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- group Description
- The association between extent of surgical resection with occurrence of complications was determined using the chi-square test.
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- OTHER
- p Value
- .0016
- param Type
- Chi-Square Test Statistic
- param Value
- 9.9111
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- .22
- upper Limit
- .44
- value
- .32
- group Id
- OG001
- lower Limit
- .10
- upper Limit
- .33
- value
- .19
- group Id
- OG002
- lower Limit
- .08
- upper Limit
- .36
- value
- .18
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 28
- units
- Participants
- title
- CR with complications
- categories
- measurements
- group Id
- OG000
- lower Limit
- .09
- upper Limit
- .21
- value
- .14
- group Id
- OG001
- lower Limit
- .07
- upper Limit
- .21
- value
- .13
- group Id
- OG002
- lower Limit
- .04
- upper Limit
- .20
- value
- .09
- denoms
- counts
- group Id
- OG000
- value
- 109
- group Id
- OG001
- value
- 94
- group Id
- OG002
- value
- 53
- units
- Participants
- title
- CR with no complications
- denoms
- counts
- group Id
- OG000
- value
- 174
- group Id
- OG001
- value
- 137
- group Id
- OG002
- value
- 81
- units
- Participants
- description
- To test for the association of the extent of surgical resection (CR vs \<CR) with surgical complications rate (complications of any kind vs no complications at all), a chi-square test will be performed.
- 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, Surgical Complication Rate
- type
- PRIMARY
- unit Of Measure
- Proportion with surgical complications
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice