Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01578239 · OUTCOME

Duration of Response (DoR)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months

What was measured

The Duration of Response (DoR) was defined as the time from initially meeting the criteria for response (CR or PR) until the time of progression by RECIST 1.1.

Analysis population: Full Analysis Set (FAS). Only Participants with an Objective Response are included in the analysis.

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-Octreotate15
Octreotide LAR4

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
177Lu-DOTA0-Tyr3-OctreotateNANot reported2.8NANA: not estimable due to number of censored participants at the time the analysis cut off date was reached.
Octreotide LAR1.9Not reported1.9NANA: not estimable due to number of censored participants at the time the analysis cut off date was reached.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA: not estimable due to number of censored participants at the time the analysis cut off date was reached.
        group Id
        OG000
        lower Limit
        2.8
        upper Limit
        NA
        value
        NA
      2. comment
        NA: not estimable due to number of censored participants at the time the analysis cut off date was reached.
        group Id
        OG001
        lower Limit
        1.9
        upper Limit
        NA
        value
        1.9
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      4
    units
    Participants
description
The Duration of Response (DoR) was defined as the time from initially meeting the criteria for response (CR or PR) until the time of progression by RECIST 1.1.
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
MEDIAN
population Description
Full Analysis Set (FAS). Only Participants with an Objective Response are included in the analysis.
reporting Status
POSTED
time Frame
From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months
title
Duration of Response (DoR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice