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NCT01578239 · OUTCOME

Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)

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.

Measure
MEAN
Unit
Scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Inclusion (Baseline) (BL), Week 72, Week 120

What was measured

The Quality of Life GI Neuroendocrine Tumor survey (QLQ GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.

Analysis population: Safety Analysis Set (SAF). Values at Inclusion were taken from last non-missing value prior to randomization (the only scheduled pre-randomization assessment was at the Baseline visit). Calculations at each visit included only participants with scores at the visit and Inclusion.

Groups in this outcome

177Lu-DOTA0-Tyr3-Octreotate

* 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.

Octreotide LAR

* 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate112
Octreotide LAR111

Reported measurements

Endocrine scale: chg from BL @ wk 72 (n=33,11)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate33
Octreotide LAR11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-8.75420.1762Not reportedNot reportedNot reported
Octreotide LAR-11.11121.0819Not reportedNot reportedNot reported
Endocrine scale: chg from BL @ wk 120 (n=2,0)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate2
Octreotide LAR0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate0.0000.0000Not reportedNot reportedNot reported
G.I. scale: chg from BL @ wk 72 (n=33,11)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate33
Octreotide LAR11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-2.72715.3083Not reportedNot reportedNot reported
Octreotide LAR2.42410.0101Not reportedNot reportedNot reported
G.I. scale: chg from BL @ wk 120 (n=2,0)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate2
Octreotide LAR0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-13.3330.0000Not reportedNot reportedNot reported
Treatment scale: chg from BL @ wk 72 (n=21,5)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate21
Octreotide LAR5
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-8.99514.9563Not reportedNot reportedNot reported
Octreotide LAR0.00011.1111Not reportedNot reportedNot reported
Treatment scale: chg from BL @ wk 120 (n=1,0)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate1
Octreotide LAR0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-16.667NANot reportedNot reportedOnly one participant analyzed
Social function scale: chg from BL @ wk 72 (n=33,11)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate33
Octreotide LAR11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-7.57623.3985Not reportedNot reportedNot reported
Octreotide LAR-7.57621.1217Not reportedNot reportedNot reported
Social function scale: chg from BL @ wk 120 (n=2,0)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate2
Octreotide LAR0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate11.1110.0000Not reportedNot reportedNot reported
Diseases rel. worries scale: chg from BL @ wk 72 (n=33,11)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate33
Octreotide LAR11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-6.06127.9289Not reportedNot reportedNot reported
Octreotide LAR1.01033.7765Not reportedNot reportedNot reported
Diseases rel. worries scale: chg from BL @ wk 120 (n=2,0)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate2
Octreotide LAR0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate33.33331.4270Not reportedNot reportedNot reported
Muscle/Bone pain symptom: chg from BL @ wk 72 (n=33,10)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate33
Octreotide LAR10
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-5.05133.4594Not reportedNot reportedNot reported
Octreotide LAR-16.66736.0041Not reportedNot reportedNot reported
Muscle/Bone pain symptom: chg from BL @ wk 120 (n=2,0)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate2
Octreotide LAR0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-16.66723.5702Not reportedNot reportedNot reported
Sexual function: chg from BL @ wk 72 (n=21,7)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate21
Octreotide LAR7
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate6.34940.3031Not reportedNot reportedNot reported
Octreotide LAR14.28617.8174Not reportedNot reportedNot reported
Sexual function: chg from BL @ wk 120 (n=2,0)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate2
Octreotide LAR0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate50.00070.7107Not reportedNot reportedNot reported
Information/Communication: chg from BL @ wk 72 (n=33,11)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate33
Octreotide LAR11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-4.04026.0309Not reportedNot reportedNot reported
Octreotide LAR-12.12130.8139Not reportedNot reportedNot reported
Information/Communication: chg from BL @ wk 120 (n=2,0)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate2
Octreotide LAR0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate0.0000.0000Not reportedNot reportedNot reported
Body image: chg from BL @ wk 72 (n=33,11)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate33
Octreotide LAR11
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate-4.04018.1766Not reportedNot reportedNot reported
Octreotide LAR-3.03017.9787Not reportedNot reportedNot reported
Body image: chg from BL @ wk 120 (n=2,0)

Analysis denominator · Participants

GroupSource count
177Lu-DOTA0-Tyr3-Octreotate2
Octreotide LAR0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate16.66723.5702Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.1762
        value
        -8.754
      2. group Id
        OG001
        spread
        21.0819
        value
        -11.111
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Endocrine scale: chg from BL @ wk 72 (n=33,11)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0000
        value
        0.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Endocrine scale: chg from BL @ wk 120 (n=2,0)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.3083
        value
        -2.727
      2. group Id
        OG001
        spread
        10.0101
        value
        2.424
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    G.I. scale: chg from BL @ wk 72 (n=33,11)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0000
        value
        -13.333
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    G.I. scale: chg from BL @ wk 120 (n=2,0)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.9563
        value
        -8.995
      2. group Id
        OG001
        spread
        11.1111
        value
        0.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Treatment scale: chg from BL @ wk 72 (n=21,5)
  6. categories
    1. measurements
      1. comment
        Only one participant analyzed
        group Id
        OG000
        spread
        NA
        value
        -16.667
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Treatment scale: chg from BL @ wk 120 (n=1,0)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.3985
        value
        -7.576
      2. group Id
        OG001
        spread
        21.1217
        value
        -7.576
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Social function scale: chg from BL @ wk 72 (n=33,11)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0000
        value
        11.111
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Social function scale: chg from BL @ wk 120 (n=2,0)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.9289
        value
        -6.061
      2. group Id
        OG001
        spread
        33.7765
        value
        1.010
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Diseases rel. worries scale: chg from BL @ wk 72 (n=33,11)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.4270
        value
        33.333
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Diseases rel. worries scale: chg from BL @ wk 120 (n=2,0)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.4594
        value
        -5.051
      2. group Id
        OG001
        spread
        36.0041
        value
        -16.667
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Muscle/Bone pain symptom: chg from BL @ wk 72 (n=33,10)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.5702
        value
        -16.667
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Muscle/Bone pain symptom: chg from BL @ wk 120 (n=2,0)
denoms
  1. counts
    1. group Id
      OG000
      value
      112
    2. group Id
      OG001
      value
      111
    units
    Participants
description
The Quality of Life GI Neuroendocrine Tumor survey (QLQ GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.
dispersion Type
Standard Deviation
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
    OG000
    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
    OG001
    title
    Octreotide LAR
param Type
MEAN
population Description
Safety Analysis Set (SAF). Values at Inclusion were taken from last non-missing value prior to randomization (the only scheduled pre-randomization assessment was at the Baseline visit). Calculations at each visit included only participants with scores at the visit and Inclusion.
reporting Status
POSTED
time Frame
Inclusion (Baseline) (BL), Week 72, Week 120
title
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)
type
SECONDARY
unit Of Measure
Scores on a scale

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Preserved source evidence · Not medical advice