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NCT01192815 · OUTCOME

Objective Response Rate

Erlotinib Hydrochloride and Radiation Therapy in Stage III-IV Squamous Cell Cancer of the Head and Neck · Source last updated 2020-05-12

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
1 year and 10 months following study start

What was measured

Number of patients with complete response, partial response, stable disease, or progressive disease. Assessed via Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Measured via conventional CT and MRI

Analysis population: One patient progressed while study was still active, study closed before follow up completed for second participant and therefore was not evaluable.

Groups in this outcome

Arm I

Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I1

Reported measurements

Source class 1

Partial response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I1Not reportedNot reportedNot reportedNot reported

Complete response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I0Not reportedNot reportedNot reportedNot reported

Stable disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I0Not reportedNot reportedNot reportedNot reported

Progressive disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      title
      Partial response
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Complete response
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Stable disease
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      Progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Number of patients with complete response, partial response, stable disease, or progressive disease. Assessed via Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Measured via conventional CT and MRI
groups
  1. description
    Patients receive erlotinib hydrochloride orally or via gastrostomy tube once daily in weeks 1-9 and then for 2 years following completion of radiation therapy. Beginning on day 1 of week 2, patients undergo radiation therapy once daily, 5 times a week, for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm I
param Type
COUNT_OF_PARTICIPANTS
population Description
One patient progressed while study was still active, study closed before follow up completed for second participant and therefore was not evaluable.
reporting Status
POSTED
time Frame
1 year and 10 months following study start
title
Objective Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice