NCT02177838 · OUTCOME

Percent of Patients Who Progress During Neoadjuvant Cetuximab by CT RECIST 1.1 Criteria

Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer · Source last updated 2021-04-21

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Day 14-21 after the first dose of cetuximab

What was measured

Among 7 patients, no one progressed during neoadjuvant cetuximab per RECIST 1.1 CT criteria (0%).

Analysis population: This measure what not evaluated because the study was halted prematurely due to low accrual.

Groups in this outcome

Treatment (Cetuximab, Cisplatin, EBRT)

Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies

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
Treatment (Cetuximab, Cisplatin, EBRT)	7

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Cetuximab, Cisplatin, EBRT)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0

denoms

counts
group Id
OG000
value
7
units
Participants

description

Among 7 patients, no one progressed during neoadjuvant cetuximab per RECIST 1.1 CT criteria (0%).

groups

description
Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
id
OG000
title
Treatment (Cetuximab, Cisplatin, EBRT)

param Type

COUNT_OF_PARTICIPANTS

population Description

This measure what not evaluated because the study was halted prematurely due to low accrual.

reporting Status

POSTED

time Frame

Day 14-21 after the first dose of cetuximab

title

Percent of Patients Who Progress During Neoadjuvant Cetuximab by CT RECIST 1.1 Criteria

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice