TriangleNCT00565851 · OUTCOME
To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- The time frame is 82.5 months (median duration of follow-up)
What was measured
The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
Analysis population: All patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol)
Groups in this outcome
No Cytoreductive Surgery
All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
Cytoreductive Surgery
All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
| Group | Source count |
|---|---|
| No Cytoreductive Surgery | 245 |
| Cytoreductive Surgery | 240 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Cytoreductive Surgery | 64.7 | Not reported | 54.5 | 73.9 | Not reported |
| Cytoreductive Surgery | 50.6 | Not reported | 44.2 | 59.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 54.5
- upper Limit
- 73.9
- value
- 64.7
- group Id
- OG001
- lower Limit
- 44.2
- upper Limit
- 59.7
- value
- 50.6
- denoms
- counts
- group Id
- OG000
- value
- 245
- group Id
- OG001
- value
- 240
- units
- Participants
- description
- The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs \> 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
- id
- OG000
- title
- No Cytoreductive Surgery
- description
- All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
- id
- OG001
- title
- Cytoreductive Surgery
- param Type
- MEDIAN
- population Description
- All patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol)
- reporting Status
- POSTED
- time Frame
- The time frame is 82.5 months (median duration of follow-up)
- title
- To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice