Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01578239 · OUTCOME

Rate of Overall Survival (OS)

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
NUMBER
Unit
Percentage of Survival Estimates
Interval / dispersion
95% Confidence Interval
Time frame
12 months, 24 months, 36 months, 48 months, 60 months

What was measured

Survival estimates were collected every 12 Months up to 60 Months to compare OS between the two treatment groups.

Analysis population: Full Analysis Set (FAS).

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-Octreotate117
Octreotide LAR114

Reported measurements

12 months
Values in Percentage of Survival Estimates · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate91.0Not reported84.095.1Not reported
Octreotide LAR79.7Not reported70.886.1Not reported
24 months
Values in Percentage of Survival Estimates · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate76.0Not reported66.783.0Not reported
Octreotide LAR62.7Not reported52.671.2Not reported
36 months
Values in Percentage of Survival Estimates · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate61.4Not reported51.469.9Not reported
Octreotide LAR50.1Not reported40.059.4Not reported
48 months
Values in Percentage of Survival Estimates · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate49.5Not reported39.558.6Not reported
Octreotide LAR41.8Not reported31.851.4Not reported
60 months
Values in Percentage of Survival Estimates · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-Octreotate37.1Not reported27.846.4Not reported
Octreotide LAR35.4Not reported25.745.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.17
    estimate Comment
    Hazard Ratio of Lu-DOTA-Tyr-Octreotate vs. Octreotide LAR
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3039
    param Type
    Cox Proportional Hazard
    param Value
    0.84
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.17
    estimate Comment
    Hazard Ratio of Lu-DOTA-Tyr-Octreotate vs. Octreotide LAR
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3039
    param Type
    Cox Proportional Hazard
    param Value
    0.84
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        84.0
        upper Limit
        95.1
        value
        91.0
      2. group Id
        OG001
        lower Limit
        70.8
        upper Limit
        86.1
        value
        79.7
    title
    12 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        66.7
        upper Limit
        83.0
        value
        76.0
      2. group Id
        OG001
        lower Limit
        52.6
        upper Limit
        71.2
        value
        62.7
    title
    24 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.4
        upper Limit
        69.9
        value
        61.4
      2. group Id
        OG001
        lower Limit
        40.0
        upper Limit
        59.4
        value
        50.1
    title
    36 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.5
        upper Limit
        58.6
        value
        49.5
      2. group Id
        OG001
        lower Limit
        31.8
        upper Limit
        51.4
        value
        41.8
    title
    48 months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.8
        upper Limit
        46.4
        value
        37.1
      2. group Id
        OG001
        lower Limit
        25.7
        upper Limit
        45.2
        value
        35.4
    title
    60 months
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      114
    units
    Participants
description
Survival estimates were collected every 12 Months up to 60 Months to compare OS between the two treatment groups.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
Full Analysis Set (FAS).
reporting Status
POSTED
time Frame
12 months, 24 months, 36 months, 48 months, 60 months
title
Rate of Overall Survival (OS)
type
SECONDARY
unit Of Measure
Percentage of Survival Estimates

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

Preserved source evidence · Not medical advice