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← CYRAMZA: metastatic gastric cancer after prior therapy

NCT02500043 · STUDY IN CONTEXT

Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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.

exploratory · POSTED

Overall response rate was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to \< 10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference.

Analysis was performed on tumor response (TR) population that included participants in the ITT population that met 2 criteria: had measurable disease (at least 1 target lesion) at baseline; had at least 1 post-baseline evaluation or early disease progression/cancer-related death occurred before first evaluation on treatment (post-baseline).

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exploratory · POSTED

DCR was defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD). The assessment of DCR was based on Investigator review of radiologic images and following RECIST criteria (version 1.1, 2009).

Analysis was performed on TR population that included participants in the ITT population that met 2 criteria: had measurable disease (at least 1 target lesion) at baseline; had at least 1 post-baseline evaluation or early disease progression/cancer-related death occurred before first evaluation on treatment (post-baseline).

→

exploratory · POSTED

The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0 = normal activity; 1= symptoms but ambulatory; 2= in bed for \< 50% of the time; 3= in bed for \> 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG performance status score from baseline was defined as a change from 0, 1 to \>=2, or from 2 to \>=3.

Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.

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primary · POSTED

OS was defined as the time from the date of randomization to the date of death due to any cause. Participants without documented death were censored at last follow-up or cut-off date, whichever comes first. OS was estimated by Kaplan-Meier method.

Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.

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secondary · POSTED

PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for target lesions were defined as target lesions with at least 20 % relative increase in the sum of diameters with reference to the smallest sum on study, including the baseline sum and this sum demonstrated an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions or Unequivocal progression of existing non-target lesions. All alive participants with no disease progression as of the analysis cut-off date were censored at the last tumor assessment. PFS was estimated by Kaplan-Meier method.

Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.

→

secondary · POSTED

Any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study medication was considered an adverse event (AE). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs/TESAEs were defined as events that started on or after treatment or started before treatment and worsened after the start of treatment through 30 days after the last dose of study treatment.

Analysis was performed on the As-treated (AT) population that included all participants who received at least 1 dose of study treatment.

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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 Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status

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-gastric-cancer-cyramza-d69c4b15
nct id
NCT02500043
qol key
qol-0006
source section id
NCT02500043-om-0006
source outcome index
6
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
measure definition
EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) and other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health and QoL, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 and 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best QoL for participant.
time frame
Baseline, Day 1 Cycle 2 up to end of treatment (EOT) (within 30 days of last study treatment) and 30-Day safety follow-up visit (maximum duration: up to approximately 46 months)
analysis role
exploratory
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. Here, 'number analyzed' = participants with available data for each specified category.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance

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

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-cyramza-d69c4b15
nct id
NCT02500043
qol key
qol-0007
source section id
NCT02500043-om-0007
source outcome index
7
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
measure definition
The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) assessed symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, dietary restrictions, pain QS22, reflux, and anxiety) and 4 single items (dry mouth, hair loss, taste problems, body image). Most questions use 4-point scale (1='Not at all', 2=a little, 3=quite a bit and 4='Very much'). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100, where higher score=better level of functioning or greater degree of symptoms.
time frame
Baseline, Cycle 1 Day 1 up to end of treatment (EOT) (within 30 days of last study treatment) (maximum duration: up to approximately 46 months)
analysis role
exploratory
reporting status
POSTED
higher is better
1
direction quote
higher score=better
population note
Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
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-gastric-cancer-cyramza-d69c4b15
nct id
NCT02500043
trial label
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0003
    source section id
    NCT02500043-om-0003
    source outcome index
    3
    endpoint
    Overall Response Rate (ORR)
    endpoint definition
    Overall response rate was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to \< 10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference.
    time origin
    From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on tumor response (TR) population that included participants in the ITT population that met 2 criteria: had measurable disease (at least 1 target lesion) at baseline; had at least 1 post-baseline evaluation or early disease progression/cancer-related death occurred before first evaluation on treatment (post-baseline).
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0004
    source section id
    NCT02500043-om-0004
    source outcome index
    4
    endpoint
    Disease Control Rate (DCR)
    endpoint definition
    DCR was defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD). The assessment of DCR was based on Investigator review of radiologic images and following RECIST criteria (version 1.1, 2009).
    time origin
    From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeks
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on TR population that included participants in the ITT population that met 2 criteria: had measurable disease (at least 1 target lesion) at baseline; had at least 1 post-baseline evaluation or early disease progression/cancer-related death occurred before first evaluation on treatment (post-baseline).
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0005
    source section id
    NCT02500043-om-0005
    source outcome index
    5
    endpoint
    Time to Deterioration of European Cooperative Oncology Group (ECOG) Performance Status Score From Baseline
    endpoint definition
    The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0 = normal activity; 1= symptoms but ambulatory; 2= in bed for \< 50% of the time; 3= in bed for \> 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG performance status score from baseline was defined as a change from 0, 1 to \>=2, or from 2 to \>=3.
    time origin
    At the time of randomization (Day 1 Cycle 1) and within 24 hours prior to start of study treatment in every cycle (maximum duration: up to approximately 46 months)
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0000
    source section id
    NCT02500043-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS was defined as the time from the date of randomization to the date of death due to any cause. Participants without documented death were censored at last follow-up or cut-off date, whichever comes first. OS was estimated by Kaplan-Meier method.
    time origin
    From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0001
    source section id
    NCT02500043-om-0001
    source outcome index
    1
    endpoint
    Progression-Free Survival (PFS)
    endpoint definition
    PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for target lesions were defined as target lesions with at least 20 % relative increase in the sum of diameters with reference to the smallest sum on study, including the baseline sum and this sum demonstrated an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions or Unequivocal progression of existing non-target lesions. All alive participants with no disease progression as of the analysis cut-off date were censored at the last tumor assessment. PFS was estimated by Kaplan-Meier method.
    time origin
    From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0002
    source section id
    NCT02500043-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)
    endpoint definition
    Any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study medication was considered an adverse event (AE). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs/TESAEs were defined as events that started on or after treatment or started before treatment and worsened after the start of treatment through 30 days after the last dose of study treatment.
    time origin
    From the first dose of study treatment until 30 days after the last dose of study treatment (maximum duration: up to approximately 46 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Analysis was performed on the As-treated (AT) population that included all participants who received at least 1 dose of study treatment.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0000
    arm key
    OG000
    arm label
    TAS-102+BSC
    regimen
    Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    337
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo+BSC
    regimen
    Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    170
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0001
    arm key
    OG000
    arm label
    TAS-102+BSC
    regimen
    Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    337
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo+BSC
    regimen
    Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    170
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0002
    arm key
    OG000
    arm label
    TAS-102+BSC
    regimen
    Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    335
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo+BSC
    regimen
    Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    168
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0003
    arm key
    OG000
    arm label
    TAS-102+BSC
    regimen
    Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    290
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo+BSC
    regimen
    Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    145
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0004
    arm key
    OG000
    arm label
    TAS-102+BSC
    regimen
    Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    290
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo+BSC
    regimen
    Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    145
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0005
    arm key
    OG000
    arm label
    TAS-102+BSC
    regimen
    Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    337
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo+BSC
    regimen
    Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
    analyzed count
    170
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02500043-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    harm key
    EG000
    source section id
    NCT02500043-ae
    event group key
    EG000
    event group label
    TAS-102+BSC
    serious affected
    143
    serious at risk
    335
    other affected
    319
    other at risk
    335
    frequency threshold
    0
    collection period
    From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
    event definition
    Analysis was performed on the AT population.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    harm key
    EG001
    source section id
    NCT02500043-ae
    event group key
    EG001
    event group label
    Placebo+BSC
    serious affected
    70
    serious at risk
    168
    other affected
    151
    other at risk
    168
    frequency threshold
    0
    collection period
    From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
    event definition
    Analysis was performed on the AT population.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    qol key
    qol-0006
    source section id
    NCT02500043-om-0006
    source outcome index
    6
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
    measure definition
    EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) and other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health and QoL, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 and 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best QoL for participant.
    time frame
    Baseline, Day 1 Cycle 2 up to end of treatment (EOT) (within 30 days of last study treatment) and 30-Day safety follow-up visit (maximum duration: up to approximately 46 months)
    analysis role
    exploratory
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. Here, 'number analyzed' = participants with available data for each specified category.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT02500043
    qol key
    qol-0007
    source section id
    NCT02500043-om-0007
    source outcome index
    7
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
    measure definition
    The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) assessed symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, dietary restrictions, pain QS22, reflux, and anxiety) and 4 single items (dry mouth, hair loss, taste problems, body image). Most questions use 4-point scale (1='Not at all', 2=a little, 3=quite a bit and 4='Very much'). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100, where higher score=better level of functioning or greater degree of symptoms.
    time frame
    Baseline, Cycle 1 Day 1 up to end of treatment (EOT) (within 30 days of last study treatment) (maximum duration: up to approximately 46 months)
    analysis role
    exploratory
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score=better
    population note
    Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
    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