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NCT01822496 · OUTCOME

Progression-free Survival

Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer · Source last updated 2019-08-05

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to study termination. Maximum follow-up was 39.0 months

What was measured

Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination.

Analysis population: Eligible patients

Groups in this outcome

EGFR: Erlotinib

Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.

EGFR: No Erlotinib

Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.

ALK: Crizotinib

Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.

ALK: No Crizotinib

Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.

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

Analysis denominator · Participants

GroupSource count
EGFR: Erlotinib14
EGFR: No Erlotinib21
ALK: Crizotinib9
ALK: No Crizotinib7

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
EGFR: Erlotinib21.1Not reported8.5NANot reached
EGFR: No Erlotinib9.2Not reported8.7NANot reached
ALK: Crizotinib14.7Not reported6.419.5Not reported
ALK: No CrizotinibNANot reportedNANANot reached
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not reached
        group Id
        OG000
        lower Limit
        8.5
        upper Limit
        NA
        value
        21.1
      2. comment
        Not reached
        group Id
        OG001
        lower Limit
        8.7
        upper Limit
        NA
        value
        9.2
      3. group Id
        OG002
        lower Limit
        6.4
        upper Limit
        19.5
        value
        14.7
      4. comment
        Not reached
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      7
    units
    Participants
description
Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination.
dispersion Type
95% Confidence Interval
groups
  1. description
    Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
    id
    OG000
    title
    EGFR: Erlotinib
  2. description
    Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
    id
    OG001
    title
    EGFR: No Erlotinib
  3. description
    Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
    id
    OG002
    title
    ALK: Crizotinib
  4. description
    Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
    id
    OG003
    title
    ALK: No Crizotinib
param Type
MEDIAN
population Description
Eligible patients
reporting Status
POSTED
time Frame
From randomization to study termination. Maximum follow-up was 39.0 months
title
Progression-free Survival
type
PRIMARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice