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NCT00686959 · FLOW

Participant flow

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.

groups
  1. description
    Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (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 milligrams per meter squared (mg/m\^2), intravenous (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 Gray \[Gy\] 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
    FG000
    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
    FG001
    title
    Arm B: Etoposide + Cisplatin and TRT
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        124
      2. group Id
        FG001
        num Subjects
        117
      type
      Participants censored (no death events)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        301
      2. group Id
        FG001
        num Subjects
        297
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        283
      2. group Id
        FG001
        num Subjects
        272
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        229
      2. group Id
        FG001
        num Subjects
        202
      type
      Entered Consolidation Phase
    4. achievements
      1. comment
        Study completion includes death due to any cause
        group Id
        FG000
        num Subjects
        177
      2. comment
        Study completion includes death due to any cause.
        group Id
        FG001
        num Subjects
        180
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        124
      2. group Id
        FG001
        num Subjects
        117
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (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 milligrams per meter squared (mg/m\^2), intravenous (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 Gray \[Gy\] 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
    FG000
    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
    FG001
    title
    Arm B: Etoposide + Cisplatin and TRT
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        124
      2. group Id
        FG001
        num Subjects
        117
      type
      Participants censored (no death events)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        301
      2. group Id
        FG001
        num Subjects
        297
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        283
      2. group Id
        FG001
        num Subjects
        272
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        229
      2. group Id
        FG001
        num Subjects
        202
      type
      Entered Consolidation Phase
    4. achievements
      1. comment
        Study completion includes death due to any cause
        group Id
        FG000
        num Subjects
        177
      2. comment
        Study completion includes death due to any cause.
        group Id
        FG001
        num Subjects
        180
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        124
      2. group Id
        FG001
        num Subjects
        117
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice