Comparison · NCT02101788-68703b7e
Arm A - Control Arm vs Arm B - Experimental Arm: Objective Tumor Response Rate (Complete Response and Partial Response)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm A - Control Arm vs Arm B - Experimental Arm: Objective Tumor Response Rate (Complete Response and Partial Response). Trial comparisons, record NCT02101788-68703b7e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02101788-68703b7e
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0615 | 0.0315 | 0.117 | wilson | |
| Risk in group 2 | 0.262 | 0.194 | 0.343 | wilson | |
| Risk difference, group 1 minus group 2 | -0.2 | -0.287 | -0.112 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.235 | 0.113 | 0.489 | log | |
| Odds ratio, group 1 over group 2 | 0.185 | 0.0819 | 0.418 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm A - Control Arm than on Arm B - Experimental Arm | 5 | 3.48 | 8.89 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm A - Control Arm | Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days | 8 | 130 | OG000 |
| Group 2 | Arm B - Experimental Arm | Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days | 34 | 130 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Objective Tumor Response Rate (Complete Response and Partial Response)
- Description
- The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.
- Time frame
- Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B
- Population
- Randomized patients
Source ClinicalTrials.gov
Trial
- Title
- Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer
- NCT number
- NCT02101788
- Phases
- PHASE2, PHASE3
- Conditions
Borderline Ovarian Serous Tumor, Micropapillary Serous Carcinoma, Ovarian Serous Adenocarcinoma, Primary Peritoneal Serous Adenocarcinoma, Recurrent Ovarian Low Grade Serous Adenocarcinoma, Recurrent Primary Peritoneal Serous Adenocarcinoma
- Interventions
- Letrozole, Paclitaxel, Pegylated Liposomal Doxorubicin Hydrochloride, Quality-of-Life Assessment, Questionnaire Administration, Tamoxifen Citrate, Topotecan, Trametinib Dimethyl Sulfoxide
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2020-09-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02101788?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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