Comparison · NCT02595879-sae
Triapine (100mg) + Chemoradiation) vs Triapine (150mg) + Chemoradiation): serious adverse events
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. Triapine (100mg) + Chemoradiation) vs Triapine (150mg) + Chemoradiation): serious adverse events. Trial comparisons, record NCT02595879-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02595879-sae
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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 | 0.471 | 0.262 | 0.69 | wilson | |
| Risk in group 2 | 0.5 | 0.15 | 0.85 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0294 | -0.437 | 0.384 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.941 | 0.313 | 2.83 | log | |
| Odds ratio, group 1 over group 2 | 0.889 | 0.101 | 7.86 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Triapine (100mg) + Chemoradiation) than on Triapine (150mg) + Chemoradiation) | 34 | 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 | Triapine (100mg) + Chemoradiation) | Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.~Biospecimen Collection: Undergo collection of blood samples~Brachytherapy: Undergo LDR brachytherapy~Cisplatin: Given IV~Computed Tomography: Undergo FDG-PET/CT~External Beam Radiation Therapy: Undergo pelvic EBRT~Fludeoxyglucose F-18: Undergo FDG-PET/CT~High-Dose Rate Brachytherapy: Undergo HDR brachytherapy~Intensity-Modulated Radiation Therapy: Undergo IMRT~Magnetic Resonance Imaging: Undergo MRI~Pharmacological Study: Correlative studies~Positron Emission Tomography: Undergo FDG-PET/CT~Triapine: Given IV and PO | 8 | 17 | EG000 |
| Group 2 | Triapine (150mg) + Chemoradiation) | Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. | 2 | 4 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 3 months post-treatment for Adverse Events Up to 4 years and 2 months for All-Cause Mortality
Source ClinicalTrials.gov
Trial
- Title
- Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
- NCT number
- NCT02595879
- Phases
- PHASE1
- Conditions
Advanced Cervical Adenocarcinoma, Advanced Cervical Adenosquamous Carcinoma, Advanced Cervical Squamous Cell Carcinoma, Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma, Advanced Vaginal Squamous Cell Carcinoma, Stage IB2 Cervical Cancer AJCC v6 and v7, Stage II Cervical Cancer AJCC v7, Stage II Vaginal Cancer AJCC v6 and v7, Stage III Vaginal Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7, Stage IVA Vaginal Cancer AJCC v6 and v7
- Interventions
Biospecimen Collection, Brachytherapy, Cisplatin, Computed Tomography, External Beam Radiation Therapy, Fludeoxyglucose F-18, High-Dose Rate Brachytherapy, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, Pharmacological Study, Positron Emission Tomography, Triapine
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2024-10-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02595879?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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