1. Trial at a Glance
| Feature | DESKTOP III |
|---|---|
| ClinicalTrials.gov ID | NCT01166737 |
| Status | COMPLETED |
| Start date | 2010-07 |
| Primary completion date | 2020-01-17 |
| Lead sponsor | AGO Study Group |
| Conditions | Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer |
| Design model | FACTORIAL |
| Masking | NONE |
2. Clinical Question
Population
Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score.
Intervention
Tumor Debulking Surgery in recurrent ovarian disease.
Comparator
Chemotherapy alone.
Primary question
Does tumor debulking surgery improve overall survival compared with chemotherapy alone?
3. Trial Design
DESKTOP III was a randomized study with two arms. The registry describes the design model as factorial and the masking as none. The study enrolled 408 participants.
| Design element | Description |
|---|---|
| Allocation | RANDOMIZED |
| Number of arms | 2 |
| Primary purpose | OTHER |
| Intervention | Tumor Debulking Surgery (surgery in recurrent ovarian disease) |
4. Endpoints
| Endpoint | Definition / timeframe |
|---|---|
| Overall survival | Approximately 36 months after last patient randomized and observation of 244 events |
The registry defines overall survival as the primary endpoint in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score.
5. Statistical Methodology
The primary outcome is a time-to-event endpoint. Overall survival is typically evaluated by estimating survival distributions, comparing randomized groups, and estimating relative differences between groups.
Kaplan-Meier estimation
Kaplan-Meier methods estimate the probability of remaining event-free over time while accounting for participants whose follow-up ends before the event occurs.
Log-rank comparison
A log-rank test is commonly used to compare survival curves between randomized groups because it evaluates differences over the observed follow-up period.
Cox proportional-hazards modeling
A Cox model is commonly used for estimating a hazard ratio, which summarizes the relative instantaneous event rate between groups under the proportional-hazards assumption.
6. Planned Analysis
The registry identifies overall survival as the primary endpoint with assessment approximately 36 months after the last patient randomized and observation of 244 events.
For an endpoint of this type, a typical analysis would include Kaplan-Meier survival estimates and a comparison of randomized treatment groups using a time-to-event statistical framework. Results have not been posted on ClinicalTrials.gov.
7. Statistical Methods Explained
Why is overall survival a time-to-event endpoint?
Overall survival records not only whether an event occurs, but also when it occurs. This allows analysis of differences in survival experience over time.
Why does randomization matter?
Randomization balances known and unknown patient characteristics on average, allowing differences observed between groups to be interpreted within the randomized comparison.
What does censoring mean?
Censoring occurs when a participant's event status is not observed through the end of follow-up. Statistical survival methods incorporate available follow-up information without assuming the exact event time is known.
What does a hazard ratio represent?
A hazard ratio compares estimated instantaneous event rates between groups. It is not the same as the percentage of patients who experience an event or a direct probability difference.
Why is follow-up time important?
Survival estimates depend on the duration and completeness of observation. Longer follow-up can provide additional information about treatment effects over time.
8. Limitations
- The registry does not report posted statistical analyses or effect estimates.
- No subgroup analyses, safety comparisons, or detailed baseline characteristics are reported in the registry information available here.
- Time-to-event interpretations depend on follow-up duration, censoring patterns, and model assumptions.
- The factorial design label is reported by the registry; additional design details are not available in the registry record summarized here.
9. Why This Trial Matters Statistically
| Concept | How it appears |
|---|---|
| Randomization | Randomized comparison of two treatment strategies |
| Survival analysis | Overall survival as the primary endpoint |
| Event-driven design | Primary endpoint assessed after observation of 244 events |
| Clinical trial design | Registry-reported factorial design model |
10. Related Tutorials
Learn more about the methods used in this trial: