Comparison · NCT01633541-e3052cb3
Platinum/Docetaxal + AT-101 vs Active Comparator Arm: Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment
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. Platinum/Docetaxal + AT-101 vs Active Comparator Arm: Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment. Trial comparisons, record NCT01633541-e3052cb3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01633541-e3052cb3
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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 | 0.794 | 0.632 | 0.897 | wilson | |
| Risk in group 2 | 0.667 | 0.437 | 0.837 | wilson | |
| Risk difference, group 1 minus group 2 | 0.127 | -0.108 | 0.378 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 0.824 | 1.72 | log | |
| Odds ratio, group 1 over group 2 | 1.93 | 0.533 | 6.97 | log | |
| Number needed to treat, for one more participant with the outcome on Platinum/Docetaxal + AT-101 than on Active Comparator Arm | 7.85 | from the risk difference interval | the interval includes no difference |
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 | Platinum/Docetaxal + AT-101 | platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.~(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).~(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.~AT-101: Patients will receive AT-101 40 mg orally two times a day.~Cisplatin: Cisplatin 100 mg/m2~Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg | 27 | 34 | OG000 |
| Group 2 | Active Comparator Arm | (Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).~Day #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.~Docetaxel: Docetaxel (Taxotere) 75 mg/m2~Cisplatin: Cisplatin 100 mg/m2~Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg | 12 | 18 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment
- Description
The primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides evidence to fully characterize clinically the effect of the treatment strategy
- Time frame
- Up to 3 months after end of treatment
- Population
Source ClinicalTrials.gov
Trial
- Title
- Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer
- NCT number
- NCT01633541
- Phases
- PHASE2
- Conditions
- Laryngeal Cancer
- Interventions
- AT-101, Docetaxel, Cisplatin, Carboplatin
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Results first posted
- 2023-07-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01633541?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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