Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Triapine · 1 trial · 21 indications
Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Arm I (cisplatin, IMRT or RT, brachytherapy) | ACTIVE_COMPARATOR | Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. |
| Arm II (cisplatin, IMRT or RT, brachytherapy, triapine) | EXPERIMENTAL | Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Brachytherapy | RADIATION | Undergo brachytherapy |
| Cisplatin | DRUG | Given IV |
| External Beam Radiation Therapy | RADIATION | Undergo EBRT |
| Intensity-Modulated Radiation Therapy | RADIATION | Undergo IMRT |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Radiation Therapy | RADIATION | Undergo conventional RT |
| Triapine | DRUG | Given IV |
Inclusion Criteria: * Patient has a new, unrated histologic diagnosis of stage IB2 (\> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to cur...