Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02177838 · OUTCOME

Locoregional Control for Non-responders to Neoadjuvant Cetuximab

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
2 years

What was measured

Among 4 cetuximab non-responders, none had locoregional failure at 2 years. Two patients had known HPV status; one patient was HPV+ and another patient HPV-. HPV status for the other two was unknown. HPV positive patient had no sign of progression within 2 years of follow-up. HPV negative patient had no sign of progression for 210 days until the last follow-up. One HPV unknown patient did not show progression within 2 years of follow-up, and the other HPV unknown patient had no progression for 115 days until the last follow-up.

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

GroupSource count
Treatment (Cetuximab, Cisplatin, EBRT)4

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Cetuximab, Cisplatin, EBRT)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Among 4 cetuximab non-responders, none had locoregional failure at 2 years. Two patients had known HPV status; one patient was HPV+ and another patient HPV-. HPV status for the other two was unknown. HPV positive patient had no sign of progression within 2 years of follow-up. HPV negative patient had no sign of progression for 210 days until the last follow-up. One HPV unknown patient did not show progression within 2 years of follow-up, and the other HPV unknown patient had no progression for 115 days until the last follow-up.
groups
  1. 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
2 years
title
Locoregional Control for Non-responders to Neoadjuvant Cetuximab
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice