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NCT01578239 · FLOW

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A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours · Source last updated 2022-04-04

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

groups
  1. description
    * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.
    id
    FG000
    title
    177Lu-DOTA0-Tyr3-Octreotate
  2. description
    * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
    id
    FG001
    title
    Octreotide LAR
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        64
      type
      Progressive Disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        17
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        10
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Non-compliance
    5. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        9
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        117
      2. group Id
        FG001
        num Subjects
        114
      comment
      All patients who received a randomization number, regardless of receiving study medication were included in the Randomized Set
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        117
      2. group Id
        FG001
        num Subjects
        114
      comment
      All randomized participant were analyzed according to randomized treatment, regardless of the actual treatment received.
      type
      Full Analysis Set (FAS)
    3. achievements
      1. group Id
        FG000
        num Subjects
        111
      2. group Id
        FG001
        num Subjects
        112
      comment
      All randomized patients who received at least one dose of active study medication. In the SAF, patients were analyzed based on actual treatment received.
      type
      Safety Analysis Set (SAF)
    4. achievements
      1. group Id
        FG000
        num Subjects
        101
      2. group Id
        FG001
        num Subjects
        99
      type
      FAS-Entered Long-term Follow-up
    5. achievements
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        13
      comment
      refers to completion of a minimum of 72 weeks of treatment.
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        101
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        64
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        10
      type
      Consent withdrawal
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Other
    milestones
    1. achievements
      1. comment
        FAS-Entered long-term follow-up
        group Id
        FG000
        num Subjects
        101
      2. comment
        FAS-Entered long-term follow-up
        group Id
        FG001
        num Subjects
        99
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        19
      comment
      Study ended 5 years from randomization of last participant or 158 deaths in the study achieved
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        80
      type
      NOT COMPLETED
    title
    Long-term Follow-Up Period
recruitment Details
The study was conducted in 41 sites across 8 countries.
Complete source fields
groups
  1. description
    * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.
    id
    FG000
    title
    177Lu-DOTA0-Tyr3-Octreotate
  2. description
    * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
    id
    FG001
    title
    Octreotide LAR
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        64
      type
      Progressive Disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        17
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        10
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Non-compliance
    5. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        9
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        117
      2. group Id
        FG001
        num Subjects
        114
      comment
      All patients who received a randomization number, regardless of receiving study medication were included in the Randomized Set
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        117
      2. group Id
        FG001
        num Subjects
        114
      comment
      All randomized participant were analyzed according to randomized treatment, regardless of the actual treatment received.
      type
      Full Analysis Set (FAS)
    3. achievements
      1. group Id
        FG000
        num Subjects
        111
      2. group Id
        FG001
        num Subjects
        112
      comment
      All randomized patients who received at least one dose of active study medication. In the SAF, patients were analyzed based on actual treatment received.
      type
      Safety Analysis Set (SAF)
    4. achievements
      1. group Id
        FG000
        num Subjects
        101
      2. group Id
        FG001
        num Subjects
        99
      type
      FAS-Entered Long-term Follow-up
    5. achievements
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        13
      comment
      refers to completion of a minimum of 72 weeks of treatment.
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        101
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        64
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        10
      type
      Consent withdrawal
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Other
    milestones
    1. achievements
      1. comment
        FAS-Entered long-term follow-up
        group Id
        FG000
        num Subjects
        101
      2. comment
        FAS-Entered long-term follow-up
        group Id
        FG001
        num Subjects
        99
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        19
      comment
      Study ended 5 years from randomization of last participant or 158 deaths in the study achieved
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        80
      type
      NOT COMPLETED
    title
    Long-term Follow-Up Period
recruitment Details
The study was conducted in 41 sites across 8 countries.

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

Preserved source evidence · Not medical advice