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NCT01578239 · OUTCOME

Change From Baseline in the EORTC QLQ-C30 Questionnaire

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 Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly transformed so each score ranged a 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).

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-Octreotate111
Octreotide LAR112

Reported measurements

Physical functioning: 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-Octreotate3.23212.4857Not reportedNot reportedNot reported
Octreotide LAR-4.24210.0101Not reportedNot reportedNot reported
Physical functioning: 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-3.3334.7140Not reportedNot reportedNot reported
Role functioning: 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-Octreotate5.05133.1989Not reportedNot reportedNot reported
Octreotide LAR-3.03016.3608Not reportedNot reportedNot reported
Role functioning: 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-Octreotate8.33311.7851Not reportedNot reportedNot reported
Emotional functioning: 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-Octreotate7.74422.6602Not reportedNot reportedNot reported
Octreotide LAR6.06117.9083Not reportedNot reportedNot reported
Emotional functioning: 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-Octreotate12.5005.8926Not reportedNot reportedNot reported
Cognitive functioning: 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-Octreotate5.55615.9571Not reportedNot reportedNot reported
Octreotide LAR1.51513.8535Not reportedNot reportedNot reported
Cognitive functioning: 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
Social functioning: 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-Octreotate8.58628.9039Not reportedNot reportedNot reported
Octreotide LAR-7.57618.8025Not reportedNot reportedNot reported
Social functioning: 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-Octreotate8.33335.3553Not reportedNot reportedNot reported
Global Health Status/QoL: 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-Octreotate5.55621.4155Not reportedNot reportedNot reported
Octreotide LAR1.51510.4205Not reportedNot reportedNot reported
Global Health Status/QoL: 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-16.6670.0000Not reportedNot reportedNot reported
Fatigue: 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-7.23924.7084Not reportedNot reportedNot reported
Octreotide LAR-2.02013.8939Not reportedNot reportedNot reported
Fatigue: 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
Nausea & Vomiting: 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-4.54515.1799Not reportedNot reportedNot reported
Octreotide LAR-4.5457.7850Not reportedNot reportedNot reported
Nausea & Vomiting: 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
Pain: 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-8.58622.4850Not reportedNot reportedNot reported
Octreotide LAR-3.03010.0504Not reportedNot reportedNot reported
Pain: 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-Octreotate0.00023.5702Not reportedNot reportedNot reported
Dyspnoea: 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-3.03022.6134Not reportedNot reportedNot reported
Octreotide LAR3.03027.7070Not reportedNot reportedNot reported
Dyspnoea: 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
Insomnia: 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-Octreotate0.00026.3523Not reportedNot reportedNot reported
Octreotide LAR6.06129.1288Not reportedNot reportedNot reported
Insomnia: 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-Octreotate33.33347.1405Not reportedNot reportedNot reported
Appetite loss: 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-8.08120.4639Not reportedNot reportedNot reported
Octreotide LAR9.09121.5557Not reportedNot reportedNot reported
Appetite loss: 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
Constipation: 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-Octreotate0.00018.6339Not reportedNot reportedNot reported
Octreotide LAR0.00014.9071Not reportedNot reportedNot reported
Constipation: 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
Diarrhoea: 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-12.12136.1499Not reportedNot reportedNot reported
Octreotide LAR-3.03027.7070Not reportedNot reportedNot reported
Diarrhoea: 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
Financial difficulties: 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-7.07133.0798Not reportedNot reportedNot reported
Octreotide LAR6.06120.1008Not reportedNot reportedNot reported
Financial difficulties: 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-16.66770.7107Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.4857
        value
        3.232
      2. group Id
        OG001
        spread
        10.0101
        value
        -4.242
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Physical functioning: chg from BL @ wk 72 (n=33,11)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.7140
        value
        -3.333
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Physical functioning: chg from BL @ wk 120 (n=2,0)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.1989
        value
        5.051
      2. group Id
        OG001
        spread
        16.3608
        value
        -3.030
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Role functioning: chg from BL @ wk 72 (n=33,11)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.7851
        value
        8.333
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Role functioning: chg from BL @ wk 120 (n=2,0)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.6602
        value
        7.744
      2. group Id
        OG001
        spread
        17.9083
        value
        6.061
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Emotional functioning: chg from BL @ wk 72 (n=33,11)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.8926
        value
        12.500
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Emotional functioning: chg from BL @ wk 120 (n=2,0)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.9571
        value
        5.556
      2. group Id
        OG001
        spread
        13.8535
        value
        1.515
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Cognitive functioning: chg from BL @ wk 72 (n=33,11)
  8. 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
    Cognitive functioning: chg from BL @ wk 120 (n=2,0)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.9039
        value
        8.586
      2. group Id
        OG001
        spread
        18.8025
        value
        -7.576
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Social functioning: chg from BL @ wk 72 (n=33,11)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.3553
        value
        8.333
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Social functioning: chg from BL @ wk 120 (n=2,0)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.4155
        value
        5.556
      2. group Id
        OG001
        spread
        10.4205
        value
        1.515
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Global Health Status/QoL: chg from BL @ wk 72 (n=33,11)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0000
        value
        -16.667
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Global Health Status/QoL: chg from BL @ wk 120 (n=2,0)
denoms
  1. counts
    1. group Id
      OG000
      value
      111
    2. group Id
      OG001
      value
      112
    units
    Participants
description
The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly transformed so each score ranged a 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
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 QLQ-C30 Questionnaire
type
SECONDARY
unit Of Measure
Scores on a scale

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

Preserved source evidence · Not medical advice