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NCT00410826 · OUTCOME

Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride

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
participants
Interval / dispersion
Not reported
Time frame
Every 3 months for up to 5 years

What was measured

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

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

GroupSource count
Arm A (Cisplatin and Radiotherapy)104
Arm B (Cisplatin, Radiotherapy, Erlotinib)99

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (Cisplatin and Radiotherapy)25Not reportedNot reportedNot reportedNot reported
Arm B (Cisplatin, Radiotherapy, Erlotinib)29Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        29
denoms
  1. counts
    1. group Id
      OG000
      value
      104
    2. group Id
      OG001
      value
      99
    units
    Participants
description
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
groups
  1. 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)
  2. 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
Every 3 months for up to 5 years
title
Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice