NCT00410826 · OUTCOME

Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm

Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer · Source last updated 2013-05-10

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: Not reported
Time frame: 12 weeks after the completion of therapy

What was measured

Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).

Groups in this outcome

Arm A (Cisplatin and Radiotherapy)

Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.

Arm B (Cisplatin, Radiotherapy, Erlotinib)

Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.

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
Arm A (Cisplatin and Radiotherapy)	96
Arm B (Cisplatin, Radiotherapy, Erlotinib)	95

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A (Cisplatin and Radiotherapy)	42	Not reported	Not reported	Not reported	Not reported
Arm B (Cisplatin, Radiotherapy, Erlotinib)	51	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
42
group Id
OG001
value
51

denoms

counts
group Id
OG000
value
96
group Id
OG001
value
95
units
Participants

description

Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).

groups

description
Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
id
OG000
title
Arm A (Cisplatin and Radiotherapy)
description
Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
id
OG001
title
Arm B (Cisplatin, Radiotherapy, Erlotinib)

param Type

NUMBER

reporting Status

POSTED

time Frame

12 weeks after the completion of therapy

title

Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm

type

PRIMARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice