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NCT02595879 · OUTCOME

Maximum Tolerated Dose (MTD)

Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer · Source last updated 2026-07-31

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

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
Up to 5 weeks

What was measured

The MTD was determined following a standard 3+3 design is as follows: Escalation at 0/3 DLTs, dose-reduction if \>1/3 DLT, and expansion to 6 if 1/3 DLTs. DLT is defined as the severe toxicity event that leads to the termination of the treatment as defined in section 5.5. The highest dose level where \<2/6 DLTs are observed will be declared MTD

Analysis population: All treated patients evaluable for DLTs

Groups in this outcome

All Participants

Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.

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

Analysis denominator · Participants

GroupSource count
All Participants9

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
The MTD was determined following a standard 3+3 design is as follows: Escalation at 0/3 DLTs, dose-reduction if \>1/3 DLT, and expansion to 6 if 1/3 DLTs. DLT is defined as the severe toxicity event that leads to the termination of the treatment as defined in section 5.5. The highest dose level where \<2/6 DLTs are observed will be declared MTD
groups
  1. description
    Patients who received at least 80% of PO triapine (either at 100mg or 150mg) and 80% of chemoradiation.
    id
    OG000
    title
    All Participants
param Type
NUMBER
population Description
All treated patients evaluable for DLTs
reporting Status
POSTED
time Frame
Up to 5 weeks
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice