NCT00117572 · OUTCOME

Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause

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: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: Up to 6 years

What was measured

Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause

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	138
Chemoradiotherapy	135

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Induction Plus Chemoradiotherapy	68.6	Not reported	60.6	76.7	Not reported
Chemoradiotherapy	58.6	Not reported	49.9	67.2	Not reported

Source statistical analyses

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

ci Lower Limit
0.51
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.12
estimate Comment
Hazard ratio is (Induction+CRT)/CRT
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.16
param Type
Hazard Ratio (HR)
param Value
0.76
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.51
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.12
estimate Comment
Hazard ratio is (Induction+CRT)/CRT
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.16
param Type
Hazard Ratio (HR)
param Value
0.76
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
60.6
upper Limit
76.7
value
68.6
group Id
OG001
lower Limit
49.9
upper Limit
67.2
value
58.6

denoms

counts
group Id
OG000
value
138
group Id
OG001
value
135
units
Participants

description

Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause

dispersion Type

95% Confidence Interval

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

NUMBER

reporting Status

POSTED

time Frame

Up to 6 years

title

Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice