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← Neuroendocrine Neoplasm

NCT01578239 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Independent Review Committee (IRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).

Full Analysis Set (FAS).

→

secondary · POSTED

Objective Response Rate (ORR) was calculated as the proportion of patients with tumour size reduction (sum of partial responses (PR) and complete responses (CR)) according to RECIST 1.1.

Full Analysis Set (FAS). Only participants with available post-baseline CT scans were considered.

→

secondary · POSTED

Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause or the date of last contact (censored observation) prior to the date of the data cut-off, and during the entire study period (i.e. the treatment period plus follow-up).

Full Analysis Set (FAS).

→

secondary · POSTED

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

Full Analysis Set (FAS).

→

secondary · POSTED

Time to Tumour Progression (TTP) was defined as the time from randomization to progression centrally assessed. It included patients who dropped out due to toxicity, but omitted patients who died without measured progression (censored to last follow-up date or death date).

Full Analysis Set (FAS).

→

secondary · POSTED

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.

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

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Change From Baseline in the EORTC QLQ-C30 Questionnaire

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-neoplasm
nct id
NCT01578239
qol key
qol-0007
source section id
NCT01578239-om-0007
source outcome index
7
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in the EORTC QLQ-C30 Questionnaire
measure definition
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).
time frame
Inclusion (Baseline) (BL), Week 72, Week 120
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher scores indicate worse
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-neoplasm
nct id
NCT01578239
qol key
qol-0008
source section id
NCT01578239-om-0008
source outcome index
8
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)
measure definition
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.
time frame
Inclusion (Baseline) (BL), Week 72, Week 120
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-neoplasm
nct id
NCT01578239
trial label
A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0000
    source section id
    NCT01578239-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Independent Review Committee (IRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).
    time origin
    From date of randomization until date of radiographic 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
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0001
    source section id
    NCT01578239-om-0001
    source outcome index
    1
    endpoint
    Objective Response Rate (ORR)
    endpoint definition
    Objective Response Rate (ORR) was calculated as the proportion of patients with tumour size reduction (sum of partial responses (PR) and complete responses (CR)) according to RECIST 1.1.
    time origin
    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
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS). Only participants with available post-baseline CT scans were considered.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0002
    source section id
    NCT01578239-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause or the date of last contact (censored observation) prior to the date of the data cut-off, and during the entire study period (i.e. the treatment period plus follow-up).
    time origin
    From date of randomization until date of death from any cause up to final safety cut-off date reached on 18Jan2021, assessed up to approximately 100 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0003
    source section id
    NCT01578239-om-0003
    source outcome index
    3
    endpoint
    Rate of Overall Survival (OS)
    endpoint definition
    Survival estimates were collected every 12 Months up to 60 Months to compare OS between the two treatment groups.
    time origin
    12 months, 24 months, 36 months, 48 months, 60 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0004
    source section id
    NCT01578239-om-0004
    source outcome index
    4
    endpoint
    Time to Tumour Progression (TTP)
    endpoint definition
    Time to Tumour Progression (TTP) was defined as the time from randomization to progression centrally assessed. It included patients who dropped out due to toxicity, but omitted patients who died without measured progression (censored to last follow-up date or death date).
    time origin
    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
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0005
    source section id
    NCT01578239-om-0005
    source outcome index
    5
    endpoint
    Duration of Response (DoR)
    endpoint definition
    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.
    time origin
    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
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS). Only Participants with an Objective Response are included in the analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0000
    arm key
    OG000
    arm label
    177Lu-DOTA0-Tyr3-Octreotate
    regimen
    * 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.
    analyzed count
    117
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Octreotide LAR
    regimen
    * 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.
    analyzed count
    114
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0001
    arm key
    OG000
    arm label
    177Lu-DOTA0-Tyr3-Octreotate
    regimen
    * 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.
    analyzed count
    102
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Octreotide LAR
    regimen
    * 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.
    analyzed count
    100
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0002
    arm key
    OG000
    arm label
    177Lu-DOTA0-Tyr3-Octreotate
    regimen
    * 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.
    analyzed count
    117
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Octreotide LAR
    regimen
    * 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.
    analyzed count
    114
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0003
    arm key
    OG000
    arm label
    177Lu-DOTA0-Tyr3-Octreotate
    regimen
    * 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.
    analyzed count
    117
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Octreotide LAR
    regimen
    * 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.
    analyzed count
    114
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0004
    arm key
    OG000
    arm label
    177Lu-DOTA0-Tyr3-Octreotate
    regimen
    * 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.
    analyzed count
    117
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Octreotide LAR
    regimen
    * 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.
    analyzed count
    114
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0005
    arm key
    OG000
    arm label
    177Lu-DOTA0-Tyr3-Octreotate
    regimen
    * 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.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Octreotide LAR
    regimen
    * 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.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01578239-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    harm key
    EG000
    source section id
    NCT01578239-ae
    event group key
    EG000
    event group label
    177Lu-DOTA0-Tyr3-Octreotate
    serious affected
    40
    serious at risk
    111
    other affected
    105
    other at risk
    111
    frequency threshold
    5
    collection period
    From informed consent signature through study completion reached at final safety cutoff date on 18July2021, assessed up to approximately 101 Months.
    event definition
    Any sign or symptom that occurs after written informed consent provided.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    harm key
    EG001
    source section id
    NCT01578239-ae
    event group key
    EG001
    event group label
    Octreotide LAR
    serious affected
    31
    serious at risk
    112
    other affected
    90
    other at risk
    112
    frequency threshold
    5
    collection period
    From informed consent signature through study completion reached at final safety cutoff date on 18July2021, assessed up to approximately 101 Months.
    event definition
    Any sign or symptom that occurs after written informed consent provided.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    qol key
    qol-0007
    source section id
    NCT01578239-om-0007
    source outcome index
    7
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in the EORTC QLQ-C30 Questionnaire
    measure definition
    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).
    time frame
    Inclusion (Baseline) (BL), Week 72, Week 120
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    higher scores indicate worse
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-neoplasm
    nct id
    NCT01578239
    qol key
    qol-0008
    source section id
    NCT01578239-om-0008
    source outcome index
    8
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)
    measure definition
    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.
    time frame
    Inclusion (Baseline) (BL), Week 72, Week 120
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice