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NCT04158141 · FLOW

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Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment (Pemetrexed and Cisplatin [or Carboplatin]) for Stage I-IIIA Malignant Pleural Mesothelioma · Source last updated 2026-07-13

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

groups
  1. description
    All patients are on Step 1 before being randomized to Step 2. STEP 1: Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
    id
    FG000
    title
    Registered, Not Yet Randomized
  2. description
    STEP 1: Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1. STEP 2: Patients receive no treatment.
    id
    FG001
    title
    Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
  3. description
    STEP 1: Same as Arm 1. STEP 2: Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
    id
    FG002
    title
    Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Does not meet requirements for Step 2
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Study terminated immediately after patient enrolled
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Eligible (Step 1)
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Patients continuing to Step 2. Patients must have received at least 2 cycles of systemic therapy and undergone a pleurectomy/decortication with the goal of macroscopic complete resection; Within 30 days prior to Step 2 randomization: no evidence of progression, ECOG Performance Status 0-1, history/physical examination occurs.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 1: Registration
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      type
      Eligible (Step 2)
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      comment
      Randomized patients contributing data to results are considered to have completed Step 2.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 2: Randomization
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      comment
      These are the randomized patients grouped to treatment arm by the treatment they \*received\* rather than the treatment they were assigned. This population is used only for the single adverse event outcome measure.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 2: As-treated Population
Complete source fields
groups
  1. description
    All patients are on Step 1 before being randomized to Step 2. STEP 1: Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
    id
    FG000
    title
    Registered, Not Yet Randomized
  2. description
    STEP 1: Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1. STEP 2: Patients receive no treatment.
    id
    FG001
    title
    Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
  3. description
    STEP 1: Same as Arm 1. STEP 2: Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
    id
    FG002
    title
    Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Does not meet requirements for Step 2
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Study terminated immediately after patient enrolled
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Eligible (Step 1)
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      comment
      Patients continuing to Step 2. Patients must have received at least 2 cycles of systemic therapy and undergone a pleurectomy/decortication with the goal of macroscopic complete resection; Within 30 days prior to Step 2 randomization: no evidence of progression, ECOG Performance Status 0-1, history/physical examination occurs.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 1: Registration
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      type
      Eligible (Step 2)
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      comment
      Randomized patients contributing data to results are considered to have completed Step 2.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 2: Randomization
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      comment
      These are the randomized patients grouped to treatment arm by the treatment they \*received\* rather than the treatment they were assigned. This population is used only for the single adverse event outcome measure.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Step 2: As-treated Population

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

Preserved source evidence · Not medical advice