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NCT01185171 · FLOW

Participant flow

Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer · Source last updated 2023-05-11

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

groups
  1. description
    Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone. Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
    id
    FG000
    title
    ZD1839 500mg by Mouth (po) Daily
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Duodenal Ulcer
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        59
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        57
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Induction Chemotherapy
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Concurrent Chemo and Radiation Treatment
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Elevated liver transaminases
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Rush
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Diarrhea
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Xerostomia
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Nausea
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Comorbid Illness
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease Recurrence
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        60
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        48
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Maintenance
pre Assignment Details
1 patient withdrew before initiating therapy and was not included in the trial. 10 patients underwent surgery to remove all gross disease before initiating study and were unevaluable for response.
recruitment Details
From February 2003 to October 2004, 70 patients signed consent at three participating institutions.
Complete source fields
groups
  1. description
    Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone. Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.
    id
    FG000
    title
    ZD1839 500mg by Mouth (po) Daily
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Duodenal Ulcer
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        59
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        57
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Induction Chemotherapy
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Concurrent Chemo and Radiation Treatment
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Elevated liver transaminases
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Rush
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Diarrhea
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Xerostomia
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Nausea
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Comorbid Illness
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Disease Recurrence
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        60
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        48
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Maintenance
pre Assignment Details
1 patient withdrew before initiating therapy and was not included in the trial. 10 patients underwent surgery to remove all gross disease before initiating study and were unevaluable for response.
recruitment Details
From February 2003 to October 2004, 70 patients signed consent at three participating institutions.

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Preserved source evidence · Not medical advice