Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02466971 · OUTCOME

Overall Survival (OS) Rate at 3 Years

Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers · Source last updated 2026-08-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
At 3 years from randomization.

What was measured

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.

Analysis population: Eligible participants

Groups in this outcome

Arm I (Cisplatin, IMRT or RT, Brachytherapy)

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. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV External Beam Radiation Therapy: Undergo EBRT Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT

Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)

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. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT Triapine: Given IV

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (Cisplatin, IMRT or RT, Brachytherapy)224
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)224

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Cisplatin, IMRT or RT, Brachytherapy)78.1Not reported7084Not reported
Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)79.6Not reported7285Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        70
        upper Limit
        84
        value
        78.1
      2. group Id
        OG001
        lower Limit
        72
        upper Limit
        85
        value
        79.6
denoms
  1. counts
    1. group Id
      OG000
      value
      224
    2. group Id
      OG001
      value
      224
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. description
    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. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV External Beam Radiation Therapy: Undergo EBRT Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT
    id
    OG000
    title
    Arm I (Cisplatin, IMRT or RT, Brachytherapy)
  2. description
    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. Brachytherapy: Undergo brachytherapy Cisplatin: Given IV Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo conventional RT Triapine: Given IV
    id
    OG001
    title
    Arm II (Cisplatin, IMRT or RT, Brachytherapy, Triapine)
param Type
NUMBER
population Description
Eligible participants
reporting Status
POSTED
time Frame
At 3 years from randomization.
title
Overall Survival (OS) Rate at 3 Years
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice