NCT01633541 · OUTCOME
Functional Assessment 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
- score 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. EATING Domain is reported here as a functional assessment.
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
| Group | Source count |
|---|
| Platinum/Docetaxal + AT-101 | 36 |
|---|
| Active Comparator Arm | 18 |
|---|
Reported measurements
EATING- Prior to treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| Platinum/Docetaxal + AT-101 | 36 |
|---|
| 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 | 83.3 | Not reported | 64.6 | 93.8 | Not reported |
|---|
| Active Comparator Arm | 91.7 | Not reported | 83.3 | 100 | Not reported |
|---|
EATING- 6 months
Analysis denominator · Participants
| Group | Source count |
|---|
| Platinum/Docetaxal + AT-101 | 24 |
|---|
| Active Comparator Arm | 18 |
|---|
Values in score on a scale · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Platinum/Docetaxal + AT-101 | 75 | Not reported | 60.4 | 85.4 | Not reported |
|---|
| Active Comparator Arm | 83.3 | Not reported | 75 | 87.5 | Not reported |
|---|
EATING- 12 months
Analysis denominator · Participants
| Group | Source count |
|---|
| Platinum/Docetaxal + AT-101 | 23 |
|---|
| 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 | 83.3 | Not reported | 66.7 | 91.7 | Not reported |
|---|
| Active Comparator Arm | 83.3 | Not reported | 62.5 | 87.5 | Not reported |
|---|
EATING- 24 months
Analysis denominator · Participants
| Group | Source count |
|---|
| Platinum/Docetaxal + AT-101 | 16 |
|---|
| 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 | 77.1 | Not reported | 67.7 | 87.5 | Not reported |
|---|
| Active Comparator Arm | 95.8 | Not reported | 75 | 95.8 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 64.6
- upper Limit
- 93.8
- value
- 83.3
- group Id
- OG001
- lower Limit
- 83.3
- upper Limit
- 100
- value
- 91.7
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- EATING- Prior to treatment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 60.4
- upper Limit
- 85.4
- value
- 75
- group Id
- OG001
- lower Limit
- 75
- upper Limit
- 87.5
- value
- 83.3
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 18
- units
- Participants
- title
- EATING- 6 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 66.7
- upper Limit
- 91.7
- value
- 83.3
- group Id
- OG001
- lower Limit
- 62.5
- upper Limit
- 87.5
- value
- 83.3
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- EATING- 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 67.7
- upper Limit
- 87.5
- value
- 77.1
- group Id
- OG001
- lower Limit
- 75
- upper Limit
- 95.8
- value
- 95.8
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- EATING- 24 months
- denoms
- counts
- group Id
- OG000
- value
- 36
- 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. EATING Domain is reported here as a functional assessment.
- 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 below based on completion compliance
- reporting Status
- POSTED
- time Frame
- Up to 28 months post treatment
- title
- Functional Assessment QOL
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle