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NCT04030455 · OUTCOME

DIGEST

Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer · Source last updated 2026-03-09

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

Measure
MEDIAN
Unit
score on a scale
Interval / dispersion
Full Range
Time frame
baseline, 6 months post treatment, long-term follow up (up to two years)

What was measured

To determine swallow function using Dynamic Imaging Grade of Swallowing Toxicity (DIGEST). DIGEST is a validated psychometric tool used during modified barium swallow studies (MBSSs) to grade swallowing safety, efficiency, and overall pharyngeal swallow function. Scores ranging from 0 to 4, where 0 indicates no impairment, 1=mild, 2=moderate, 3=severe, 4=life threatening. The DIGEST grade was collected at three time points: baseline, 6 months post-treatment and long-term follow-up. One subject without any DIGEST data was excluded from analysis. A linear mixed-effects model was used to evaluate the effects of treatment group (chemo-IO alone vs. radiation/surgery) and time on DIGEST grade across three time points.

Groups in this outcome

Experimental (Cis/Doce/Pembro)

cis 75 mg/m2 (SOC), doce 74 mg/m2 (SOC), pembro 200mg (Exp), Q3W 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
Experimental (Cis/Doce/Pembro)23

Reported measurements

DIGEST grade for Chemo-IO alone treatment group: Baseline
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Experimental (Cis/Doce/Pembro)0Not reported02Not reported
DIGEST grade for Chemo-IO alone treatment group: 6M Post
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Experimental (Cis/Doce/Pembro)1Not reported01Not reported
DIGEST grade for Chemo-IO alone treatment group: Long Term FU
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Experimental (Cis/Doce/Pembro)0Not reported01Not reported
DIGEST grade for RT/Surgery treatment group: Baseline
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Experimental (Cis/Doce/Pembro)1Not reported02Not reported
DIGEST grade for RT/Surgery treatment group: 6M Post
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Experimental (Cis/Doce/Pembro)2Not reported03Not reported
DIGEST grade for RT/Surgery treatment group: Long Term FU
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Experimental (Cis/Doce/Pembro)1Not reported03Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        2
        value
        0
    title
    DIGEST grade for Chemo-IO alone treatment group: Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        1
        value
        1
    title
    DIGEST grade for Chemo-IO alone treatment group: 6M Post
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        1
        value
        0
    title
    DIGEST grade for Chemo-IO alone treatment group: Long Term FU
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        2
        value
        1
    title
    DIGEST grade for RT/Surgery treatment group: Baseline
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        3
        value
        2
    title
    DIGEST grade for RT/Surgery treatment group: 6M Post
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        3
        value
        1
    title
    DIGEST grade for RT/Surgery treatment group: Long Term FU
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
To determine swallow function using Dynamic Imaging Grade of Swallowing Toxicity (DIGEST). DIGEST is a validated psychometric tool used during modified barium swallow studies (MBSSs) to grade swallowing safety, efficiency, and overall pharyngeal swallow function. Scores ranging from 0 to 4, where 0 indicates no impairment, 1=mild, 2=moderate, 3=severe, 4=life threatening. The DIGEST grade was collected at three time points: baseline, 6 months post-treatment and long-term follow-up. One subject without any DIGEST data was excluded from analysis. A linear mixed-effects model was used to evaluate the effects of treatment group (chemo-IO alone vs. radiation/surgery) and time on DIGEST grade across three time points.
dispersion Type
Full Range
groups
  1. description
    cis 75 mg/m2 (SOC), doce 74 mg/m2 (SOC), pembro 200mg (Exp), Q3W IV
    id
    OG000
    title
    Experimental (Cis/Doce/Pembro)
param Type
MEDIAN
reporting Status
POSTED
time Frame
baseline, 6 months post treatment, long-term follow up (up to two years)
title
DIGEST
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice