Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01633541 · OUTCOME

Head and Neck Related Quality of Life (QOL)

Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer · Source last updated 2023-07-20

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

Measure
MEDIAN
Unit
units on a scale
Interval / dispersion
Inter-Quartile Range
Time frame
Up to 28 months post treatment

What was measured

University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome.

Analysis population: Number of participants analyzed varies below based on completion compliance

Groups in this outcome

Platinum/Docetaxal + AT-101

platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist. Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). (AT-101 Arm) Days #1-3: Patients received AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy. AT-101: Patients received AT-101 40 mg orally two times a day. Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg

Active Comparator Arm

Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). Day #23 (+/- 3 days): Patients underwent a direct laryngoscopy (DL) with biopsy. Patients also underwent a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies. Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg

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

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10136
Active Comparator Arm18

Reported measurements

Emotion- Prior to treatment

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10135
Active Comparator Arm17
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10166.7Not reported41.779.2Not reported
Active Comparator Arm62.5Not reported58.375Not reported
Emotion- 6 months

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10124
Active Comparator Arm11
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10166.7Not reported41.795.8Not reported
Active Comparator Arm95.8Not reported75.0100Not reported
Emotion- 12 months

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10122
Active Comparator Arm11
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10172.9Not reported66.783.3Not reported
Active Comparator Arm91.7Not reported75100Not reported
Emotion- 24 months

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10116
Active Comparator Arm9
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10175Not reported52.181.3Not reported
Active Comparator Arm91.7Not reported91.795.8Not reported
Speech- Prior to treatment

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10136
Active Comparator Arm18
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10146.9Not reported37.562.5Not reported
Active Comparator Arm34.4Not reported2568.8Not reported
Speech- 6 Months

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10124
Active Comparator Arm11
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10156.3Not reported21.978.1Not reported
Active Comparator Arm50Not reported37.581.3Not reported
Speech- 12 Months

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10123
Active Comparator Arm11
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10150Not reported31.375Not reported
Active Comparator Arm62.5Not reported18.887.5Not reported
Speech- 24 Months

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10115
Active Comparator Arm9
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10150Not reported43.875Not reported
Active Comparator Arm75Not reported5087.5Not reported
Pain- Prior to treatment

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10136
Active Comparator Arm17
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10159.4Not reported43.875Not reported
Active Comparator Arm68.8Not reported56.387.5Not reported
Pain- 6 months

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10124
Active Comparator Arm11
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10162.5Not reported31.387.5Not reported
Active Comparator Arm81.3Not reported62.587.5Not reported
Pain- 12 months

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10123
Active Comparator Arm10
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10168.8Not reported43.891.7Not reported
Active Comparator Arm62.5Not reported58.387.5Not reported
Pain- 24 months

Analysis denominator · Participants

GroupSource count
Platinum/Docetaxal + AT-10116
Active Comparator Arm9
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Platinum/Docetaxal + AT-10156.3Not reported28.187.5Not reported
Active Comparator Arm87.5Not reported7593.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41.7
        upper Limit
        79.2
        value
        66.7
      2. group Id
        OG001
        lower Limit
        58.3
        upper Limit
        75
        value
        62.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Emotion- Prior to treatment
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41.7
        upper Limit
        95.8
        value
        66.7
      2. group Id
        OG001
        lower Limit
        75.0
        upper Limit
        100
        value
        95.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Emotion- 6 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        66.7
        upper Limit
        83.3
        value
        72.9
      2. group Id
        OG001
        lower Limit
        75
        upper Limit
        100
        value
        91.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Emotion- 12 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52.1
        upper Limit
        81.3
        value
        75
      2. group Id
        OG001
        lower Limit
        91.7
        upper Limit
        95.8
        value
        91.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Emotion- 24 months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.5
        upper Limit
        62.5
        value
        46.9
      2. group Id
        OG001
        lower Limit
        25
        upper Limit
        68.8
        value
        34.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Speech- Prior to treatment
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.9
        upper Limit
        78.1
        value
        56.3
      2. group Id
        OG001
        lower Limit
        37.5
        upper Limit
        81.3
        value
        50
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Speech- 6 Months
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.3
        upper Limit
        75
        value
        50
      2. group Id
        OG001
        lower Limit
        18.8
        upper Limit
        87.5
        value
        62.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Speech- 12 Months
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43.8
        upper Limit
        75
        value
        50
      2. group Id
        OG001
        lower Limit
        50
        upper Limit
        87.5
        value
        75
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Speech- 24 Months
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43.8
        upper Limit
        75
        value
        59.4
      2. group Id
        OG001
        lower Limit
        56.3
        upper Limit
        87.5
        value
        68.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Pain- Prior to treatment
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.3
        upper Limit
        87.5
        value
        62.5
      2. group Id
        OG001
        lower Limit
        62.5
        upper Limit
        87.5
        value
        81.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Pain- 6 months
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43.8
        upper Limit
        91.7
        value
        68.8
      2. group Id
        OG001
        lower Limit
        58.3
        upper Limit
        87.5
        value
        62.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Pain- 12 months
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.1
        upper Limit
        87.5
        value
        56.3
      2. group Id
        OG001
        lower Limit
        75
        upper Limit
        93.8
        value
        87.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Pain- 24 months
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      18
    units
    Participants
description
University of Michigan Head and Neck Quality of Life Instrument (HN-QOL) will be administered prior to treatment (i.e. pre-induction chemotherapy) and at 6 months, 12 months, and 24 months (+/- 4 months) after completion of chemo-RT or surgery-RT (or surgery-chemoRT, as indicated). Scale is 0-100 with high scores indicating a better outcome.
dispersion Type
Inter-Quartile Range
groups
  1. description
    platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist. Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). (AT-101 Arm) Days #1-3: Patients received AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy. AT-101: Patients received AT-101 40 mg orally two times a day. Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
    id
    OG000
    title
    Platinum/Docetaxal + AT-101
  2. description
    Patients underwent induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6). Day #23 (+/- 3 days): Patients underwent a direct laryngoscopy (DL) with biopsy. Patients also underwent a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies. Docetaxel: Docetaxel (Taxotere) 75 mg/m2 Cisplatin: Cisplatin 100 mg/m2 Carboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
    id
    OG001
    title
    Active Comparator Arm
param Type
MEDIAN
population Description
Number of participants analyzed varies below based on completion compliance
reporting Status
POSTED
time Frame
Up to 28 months post treatment
title
Head and Neck Related Quality of Life (QOL)
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice