NCT00084318 · OUTCOME

Overall Survival

Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck · Source last updated 2018-12-12

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: From randomization to 2 years

What was measured

Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).

Analysis population: Eligible patients who started protocol treatment and did not withdraw consent

Groups in this outcome

RT + Cisplatin + Cetuximab

Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.

RT + Docetaxel + Cetuximab

Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.

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
RT + Cisplatin + Cetuximab	97
RT + Docetaxel + Cetuximab	106

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
RT + Cisplatin + Cetuximab	68.8	Not reported	59.5	78	Not reported
RT + Docetaxel + Cetuximab	79.2	Not reported	71.4	86.9	Not reported

Source statistical analyses

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

ci Lower Limit
0.5
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.03
estimate Comment
Reference arm = historical control
group Description
Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.04
param Type
Hazard Ratio (HR)
param Value
0.72
statistical Comment
Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).
statistical Method
Log Rank
ci Lower Limit
0.39
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.82
estimate Comment
Reference arm = historical control
group Description
Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model.
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.001
param Type
Hazard Ratio (HR)
param Value
0.56
statistical Comment
Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.5
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.03
estimate Comment
Reference arm = historical control
group Description
Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.04
param Type
Hazard Ratio (HR)
param Value
0.72
statistical Comment
Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).
statistical Method
Log Rank
ci Lower Limit
0.39
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.82
estimate Comment
Reference arm = historical control
group Description
Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model.
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.001
param Type
Hazard Ratio (HR)
param Value
0.56
statistical Comment
Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
59.5
upper Limit
78
value
68.8
group Id
OG001
lower Limit
71.4
upper Limit
86.9
value
79.2

denoms

counts
group Id
OG000
value
97
group Id
OG001
value
106
units
Participants

description

Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).

dispersion Type

95% Confidence Interval

groups

description
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
id
OG000
title
RT + Cisplatin + Cetuximab
description
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
id
OG001
title
RT + Docetaxel + Cetuximab

param Type

NUMBER

population Description

Eligible patients who started protocol treatment and did not withdraw consent

reporting Status

POSTED

time Frame

From randomization to 2 years

title

Overall Survival

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice