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
score on a scale
Interval / dispersion
Inter-Quartile Range
Time frame
Up to 28 months post treatment
What was measured
The University of Michigan Voice Related Quality of Life Measure (V-RQOL) 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 0-50 (10 items scale 1-5) with high scores indicating a worse outcome.
Analysis population: number of participants analyzed varies due to patient compliance and patients coming off trial per protocol
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
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Reported measurements
VRQOL-SUM- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
25
Not reported
18
29
Not reported
Active Comparator Arm
24
Not reported
20
34
Not reported
VRQOL-SUM- 6 Months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
23
Not reported
13
32
Not reported
Active Comparator Arm
23
Not reported
14
28
Not reported
VRQOL-SUM- 12 Months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
26
Not reported
17
32.5
Not reported
Active Comparator Arm
22
Not reported
13
31
Not reported
VRQOL-SUM- 24 Months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
22
Not reported
15
32
Not reported
Active Comparator Arm
21
Not reported
15
23
Not reported
NOISY_VAL_- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
4
Not reported
3
4
Not reported
Active Comparator Arm
4
Not reported
3
4
Not reported
NOISY_VAL_- 6months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
2
4
Not reported
Active Comparator Arm
3
Not reported
2
5
Not reported
NOISY_VAL_- 12 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
4
Not reported
3
4.5
Not reported
Active Comparator Arm
3
Not reported
2
4
Not reported
NOISY_VAL_- 24 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
2
5
Not reported
Active Comparator Arm
4
Not reported
3
4
Not reported
OUTOFAIR_VAL- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
2
Not reported
Active Comparator Arm
2
Not reported
1
3
Not reported
OUTOFAIR_VAL- 6 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
1
Not reported
1
3
Not reported
OUTOFAIR_VAL- 12 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
2
Not reported
1
3
Not reported
OUTOFAIR_VAL- 24 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
1
Not reported
1
3
Not reported
WHATCOMEOUT_VAL_3n- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
1
Not reported
1
3
Not reported
Active Comparator Arm
1
Not reported
1
3
Not reported
WHATCOMEOUT_VAL_3n- 6 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
2
Not reported
1
3
Not reported
WHATCOMEOUT_VAL_3n- 12 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
2
Not reported
Active Comparator Arm
1
Not reported
1
3
Not reported
WHATCOMEOUT_VAL_3n- 24 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
2
Not reported
1
2
Not reported
ANXIOUS_VAL_4n- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
1
4
Not reported
Active Comparator Arm
3
Not reported
2
3
Not reported
ANXIOUS_VAL_4n- 6 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
1
4
Not reported
Active Comparator Arm
2
Not reported
1
3
Not reported
ANXIOUS_VAL_4n- 12 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2.5
Not reported
2
4
Not reported
Active Comparator Arm
2
Not reported
1
3
Not reported
ANXIOUS_VAL_4n- 24 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
2
4
Not reported
Active Comparator Arm
2
Not reported
1
4
Not reported
DEPRESSED_VAL_5n- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
2
Not reported
1
3
Not reported
DEPRESSED_VAL_5n- 6 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
1
Not reported
1
2
Not reported
DEPRESSED_VAL_5n- 12 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
1
Not reported
1
1
Not reported
DEPRESSED_VAL_5n- 24 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
4
Not reported
Active Comparator Arm
1
Not reported
1
2
Not reported
TROUBLEPHONE_VAL_6n- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
2
4
Not reported
Active Comparator Arm
3
Not reported
3
4
Not reported
TROUBLEPHONE_VAL_6n- 6 Months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
2
4
Not reported
Active Comparator Arm
2
Not reported
1
4
Not reported
TROUBLEPHONE_VAL_6n- 12 Months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
2
4
Not reported
Active Comparator Arm
3
Not reported
1
3
Not reported
TROUBLEPHONE_VAL_6n- 24 Months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
1
4
Not reported
Active Comparator Arm
2
Not reported
2
2
Not reported
TROUBLEJOB_VAL_7n- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
2
Not reported
1
4
Not reported
TROUBLEJOB_VAL_7n- 6 Months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
1
Not reported
1
4
Not reported
Active Comparator Arm
1
Not reported
1
2
Not reported
TROUBLEJOB_VAL_7n- 12 Months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2.5
Not reported
1
3
Not reported
Active Comparator Arm
1
Not reported
1
3
Not reported
TROUBLEJOB_VAL_7n- 24 Months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
4
Not reported
Active Comparator Arm
1
Not reported
1
2
Not reported
AVOIDSOCIALLY_VAL_8n- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
1
Not reported
1
2
Not reported
Active Comparator Arm
2
Not reported
1
4
Not reported
AVOIDSOCIALLY_VAL_8n- 6 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
2
Not reported
1
4
Not reported
AVOIDSOCIALLY_VAL_8n- 12 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
1.5
Not reported
1
3
Not reported
Active Comparator Arm
2
Not reported
1
3
Not reported
AVOIDSOCIALLY_VAL_8n- 24 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
1
Not reported
1
2
Not reported
REPEATMYSELF_VAL_9n- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
2
4
Not reported
Active Comparator Arm
3
Not reported
2
4
Not reported
REPEATMYSELF_VAL_9n- 6 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
2
4
Not reported
Active Comparator Arm
3
Not reported
2
4
Not reported
REPEATMYSELF_VAL_9n- 12 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
3
Not reported
2
4
Not reported
Active Comparator Arm
3
Not reported
2
4
Not reported
REPEATMYSELF_VAL_9n- 24 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
4
Not reported
Active Comparator Arm
3
Not reported
2
4
Not reported
LESSOUTGOING_VAL_10n- Prior to treatment
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
35
Active Comparator Arm
17
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
3
Not reported
1
4
Not reported
LESSOUTGOING_VAL_10n- 6 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
22
Active Comparator Arm
11
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
4
Not reported
Active Comparator Arm
2
Not reported
1
3
Not reported
LESSOUTGOING_VAL_10n- 12 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
20
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
2
Not reported
1
3
Not reported
LESSOUTGOING_VAL_10n- 24 months
Analysis denominator · Participants
Group
Source count
Platinum/Docetaxal + AT-101
13
Active Comparator Arm
9
Values in score on a scale · Interval/dispersion: Inter-Quartile Range
Group
Value
Spread
Lower
Upper
Comment
Platinum/Docetaxal + AT-101
2
Not reported
1
3
Not reported
Active Comparator Arm
2
Not reported
1
2
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
18
upper Limit
29
value
25
group Id
OG001
lower Limit
20
upper Limit
34
value
24
denoms
counts
group Id
OG000
value
35
group Id
OG001
value
17
units
Participants
title
VRQOL-SUM- Prior to treatment
categories
measurements
group Id
OG000
lower Limit
13
upper Limit
32
value
23
group Id
OG001
lower Limit
14
upper Limit
28
value
23
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
11
units
Participants
title
VRQOL-SUM- 6 Months
categories
measurements
group Id
OG000
lower Limit
17
upper Limit
32.5
value
26
group Id
OG001
lower Limit
13
upper Limit
31
value
22
denoms
counts
group Id
OG000
value
20
group Id
OG001
value
9
units
Participants
title
VRQOL-SUM- 12 Months
categories
measurements
group Id
OG000
lower Limit
15
upper Limit
32
value
22
group Id
OG001
lower Limit
15
upper Limit
23
value
21
denoms
counts
group Id
OG000
value
13
group Id
OG001
value
9
units
Participants
title
VRQOL-SUM- 24 Months
categories
measurements
group Id
OG000
lower Limit
3
upper Limit
4
value
4
group Id
OG001
lower Limit
3
upper Limit
4
value
4
denoms
counts
group Id
OG000
value
35
group Id
OG001
value
17
units
Participants
title
NOISY_VAL_- Prior to treatment
categories
measurements
group Id
OG000
lower Limit
2
upper Limit
4
value
3
group Id
OG001
lower Limit
2
upper Limit
5
value
3
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
11
units
Participants
title
NOISY_VAL_- 6months
categories
measurements
group Id
OG000
lower Limit
3
upper Limit
4.5
value
4
group Id
OG001
lower Limit
2
upper Limit
4
value
3
denoms
counts
group Id
OG000
value
20
group Id
OG001
value
9
units
Participants
title
NOISY_VAL_- 12 months
categories
measurements
group Id
OG000
lower Limit
2
upper Limit
5
value
3
group Id
OG001
lower Limit
3
upper Limit
4
value
4
denoms
counts
group Id
OG000
value
13
group Id
OG001
value
9
units
Participants
title
NOISY_VAL_- 24 months
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
2
value
2
group Id
OG001
lower Limit
1
upper Limit
3
value
2
denoms
counts
group Id
OG000
value
35
group Id
OG001
value
17
units
Participants
title
OUTOFAIR_VAL- Prior to treatment
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
3
value
2
group Id
OG001
lower Limit
1
upper Limit
3
value
1
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
11
units
Participants
title
OUTOFAIR_VAL- 6 months
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
3
value
2
group Id
OG001
lower Limit
1
upper Limit
3
value
2
denoms
counts
group Id
OG000
value
20
group Id
OG001
value
9
units
Participants
title
OUTOFAIR_VAL- 12 months
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
3
value
2
group Id
OG001
lower Limit
1
upper Limit
3
value
1
denoms
counts
group Id
OG000
value
13
group Id
OG001
value
9
units
Participants
title
OUTOFAIR_VAL- 24 months
denoms
counts
group Id
OG000
value
35
group Id
OG001
value
17
units
Participants
description
The University of Michigan Voice Related Quality of Life Measure (V-RQOL) 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 0-50 (10 items scale 1-5) with high scores indicating a worse outcome.
dispersion Type
Inter-Quartile Range
groups
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
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 due to patient compliance and patients coming off trial per protocol
Triangle