NCT00117572 · OUTCOME

Quality of Life (McMaster)

Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE) · Source last updated 2018-04-09

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

Measure: MEAN
Unit: units on a scale
Interval / dispersion: Standard Error
Time frame: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.

What was measured

McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)

Analysis population: Survivors who completed the questionnaire. (Patients with missing data excluded.)

Groups in this outcome

Induction Plus Chemoradiotherapy

Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details

Chemoradiotherapy

Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details

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
Induction Plus Chemoradiotherapy	76
Chemoradiotherapy	84

Reported measurements

Source class 1

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Induction Plus Chemoradiotherapy	-9.72	0.90	Not reported	Not reported	Not reported
Chemoradiotherapy	-9.79	0.86	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.96
statistical Method
t-test, 2 sided

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.96
statistical Method
t-test, 2 sided

classes

categories
measurements
group Id
OG000
spread
0.90
value
-9.72
group Id
OG001
spread
0.86
value
-9.79

denoms

counts
group Id
OG000
value
76
group Id
OG001
value
84
units
Participants

description

McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)

dispersion Type

Standard Error

groups

description
Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) cisplatin: 75 mg/m2 on day 1 hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
id
OG000
title
Induction Plus Chemoradiotherapy
description
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. docetaxel: 75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) hydroxyurea: Each cycle: 500 mg PO q 12 hours x 6 days (11 doses) fluorouracil: 750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) chemotherapy: See protocol for details radiotherapy: See protocol for details
id
OG001
title
Chemoradiotherapy

param Type

MEAN

population Description

Survivors who completed the questionnaire. (Patients with missing data excluded.)

reporting Status

POSTED

time Frame

Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.

title

Quality of Life (McMaster)

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice