1. Trial at a Glance
MITO-7 was a randomized phase 3 study evaluating chemotherapy scheduling approaches in patients with ovarian cancer.
| Feature | MITO-7 |
|---|---|
| Condition | Ovarian Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None |
| Primary purpose | Treatment |
| Sponsor | National Cancer Institute, Naples |
| Study period | Start date: 2008-11; Primary completion date: 2024-11 |
2. Clinical Question
Population
Patients with ovarian cancer.
Intervention
Weekly chemotherapy schedule using carboplatin and paclitaxel.
Comparator
Every 3 week chemotherapy schedule using carboplatin and paclitaxel.
Primary question
Does the chemotherapy schedule affect quality of life and progression free survival?
3. Trial Design
The registry describes MITO-7 as a randomized, parallel, open-label phase 3 treatment study with two intervention arms.
| Design element | Description |
|---|---|
| Allocation | Randomized |
| Arms | 2 |
| Masking | None |
| Interventions | Carboplatin and paclitaxel |
4. Endpoints
| Endpoint | Registry definition / time frame |
|---|---|
| Quality of life | Weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy |
| Progression free survival | Every 6 months |
5. Planned Analysis
The ClinicalTrials.gov record identifies quality of life and progression free survival as primary endpoints. Results and formal statistical analyses are not posted in the registry record.
Quality-of-life endpoints are commonly analyzed using repeated assessments over time, accounting for within-patient correlation across visits. Progression-free survival is typically analyzed as a time-to-event endpoint using methods such as Kaplan-Meier estimation, log-rank comparisons, and regression models for hazard ratios when prespecified.
6. Statistical Methodology
Time-to-event analysis
Progression-free survival measures time until disease progression or another defined event. Because some participants may not have experienced an event at the time of analysis, methods must account for censored observations.
Kaplan-Meier estimation
The Kaplan-Meier method estimates the probability of remaining event-free over time while incorporating participants whose follow-up ends before an event occurs.
Longitudinal quality-of-life analysis
Repeated quality-of-life measurements require methods that consider multiple observations from the same participant. Common approaches include mixed-effects models or other repeated-measures techniques, depending on the prespecified analysis plan.
7. Statistical Methods Explained
Why is progression-free survival analyzed as a time-to-event endpoint?
Because participants may experience progression at different times, the analysis focuses on the distribution of event times rather than only whether an event occurred.
Why does censoring matter?
A participant without a documented progression event still contributes follow-up information until the last assessment. Censoring methods prevent simply excluding these observations.
Why are repeated quality-of-life measurements statistically challenging?
Measurements from the same patient are correlated. Treating each observation as independent can underestimate uncertainty.
What does randomization accomplish?
Randomization balances measured and unmeasured factors between groups on average, allowing differences in outcomes to be interpreted within the randomized comparison framework.
8. Limitations
- The ClinicalTrials.gov record does not report endpoint estimates, confidence intervals, or p-values.
- The registry does not provide posted statistical analyses for the primary endpoints.
- The registry does not report subgroup analyses, safety comparisons, interim analyses, multiplicity procedures, or missing-data methods.
- Without posted results, the comparative effect of the two chemotherapy schedules cannot be evaluated from the registry record alone.
9. Why This Trial Matters Statistically
| Concept | How it appears in MITO-7 |
|---|---|
| Randomization | Randomized comparison of chemotherapy schedules |
| Time-to-event methods | Progression-free survival endpoint |
| Longitudinal analysis | Repeated quality-of-life measurements |
| Open-label design | No masking |
10. Related Tutorials
11. Related Calculators
12. Sources
- ClinicalTrials.gov record: NCT00660842
- PubMed: MITO-7 publication record