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NCT04541355 · OUTCOME

Proportion of Participants With Reported High Grade Ototoxicity

Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin · Source last updated 2024-06-28

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
Not reported
Time frame
Up to 18 weeks

What was measured

The proportion of participants with a reported change of grade \>= 2 hearing impairments based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (for patients on a monitoring program with audiogram) will be reported.

Groups in this outcome

Cisplatin, Radiotherapy, STS

Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Cisplatin, Radiotherapy, STS16

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin, Radiotherapy, STS0.18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.18
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
The proportion of participants with a reported change of grade \>= 2 hearing impairments based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (for patients on a monitoring program with audiogram) will be reported.
groups
  1. description
    Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Cisplatin, Radiotherapy, STS
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 18 weeks
title
Proportion of Participants With Reported High Grade Ototoxicity
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice