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NCT00686959 · OUTCOME

First Site of Disease Failure in Terms of Relapse

Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer · Source last updated 2016-06-28

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to Relapse (Up to 66.6 Months)

What was measured

The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.

Analysis population: All randomized participants with objective PD.

Groups in this outcome

Arm A: Pemetrexed + Cisplatin and TRT

Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles

Arm B: Etoposide + Cisplatin and TRT

Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22

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: Pemetrexed + Cisplatin and TRT166
Arm B: Etoposide + Cisplatin and TRT190

Reported measurements

Relapsed within the radiation treatment field
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Pemetrexed + Cisplatin and TRT37.3Not reported30.045.2Not reported
Arm B: Etoposide + Cisplatin and TRT45.8Not reported38.653.2Not reported
Relapsed inside thorax, outside of radiation field
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Pemetrexed + Cisplatin and TRT20.5Not reported14.627.4Not reported
Arm B: Etoposide + Cisplatin and TRT16.3Not reported11.422.4Not reported
Relapsed distant disease
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Pemetrexed + Cisplatin and TRT50.0Not reported42.257.8Not reported
Arm B: Etoposide + Cisplatin and TRT45.8Not reported38.653.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Description
    Relapsed within the radiation treatment field
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.132
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
  2. ci Num Sides
    TWO_SIDED
    group Description
    Relapsed inside thorax, outside of radiation field
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.337
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
  3. ci Num Sides
    TWO_SIDED
    group Description
    Relapsed distant disease
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.457
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    Relapsed within the radiation treatment field
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.132
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
  2. ci Num Sides
    TWO_SIDED
    group Description
    Relapsed inside thorax, outside of radiation field
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.337
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
  3. ci Num Sides
    TWO_SIDED
    group Description
    Relapsed distant disease
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.457
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.0
        upper Limit
        45.2
        value
        37.3
      2. group Id
        OG001
        lower Limit
        38.6
        upper Limit
        53.2
        value
        45.8
    title
    Relapsed within the radiation treatment field
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.6
        upper Limit
        27.4
        value
        20.5
      2. group Id
        OG001
        lower Limit
        11.4
        upper Limit
        22.4
        value
        16.3
    title
    Relapsed inside thorax, outside of radiation field
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.2
        upper Limit
        57.8
        value
        50.0
      2. group Id
        OG001
        lower Limit
        38.6
        upper Limit
        53.2
        value
        45.8
    title
    Relapsed distant disease
denoms
  1. counts
    1. group Id
      OG000
      value
      166
    2. group Id
      OG001
      value
      190
    units
    Participants
description
The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
    id
    OG000
    title
    Arm A: Pemetrexed + Cisplatin and TRT
  2. description
    Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
    id
    OG001
    title
    Arm B: Etoposide + Cisplatin and TRT
param Type
NUMBER
population Description
All randomized participants with objective PD.
reporting Status
POSTED
time Frame
Baseline to Relapse (Up to 66.6 Months)
title
First Site of Disease Failure in Terms of Relapse
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice