ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

Draft scope assessment: unclear. Attached because the study's own record names HER2. 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.

primary · POSTED

OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

FAS

→

secondary · POSTED

PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

FAS

→

secondary · POSTED

The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.

FAS

→

secondary · POSTED

TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.

FAS

→

secondary · POSTED

The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.

FAS

→

secondary · POSTED

For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.

FAS

→

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 · European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores

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-ontruzant-6c14b147
nct id: NCT01041404
qol key: qol-0010
source section id: NCT01041404-om-0010
source outcome index: 10
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
measure definition: EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.
time frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher score equals (=) better
population note: FAS; n (number) = number of participants assessed for a specific parameter at a given visit.
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-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores

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-ontruzant-6c14b147
nct id: NCT01041404
qol key: qol-0011
source section id: NCT01041404-om-0011
source outcome index: 11
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
measure definition: The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.
time frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher score=better
population note: FAS; n = number of participants assessed for a specific parameter at a given visit.
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-ontruzant-6c14b147
nct id: NCT01041404
trial label: ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer
applicability: unclear
applicability note: Attached because the study's own record names HER2. 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

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0000
source section id
NCT01041404-om-0000
source outcome index
0
endpoint
Overall Survival (OS) - Percentage of Participants With an Event
endpoint definition
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.
time origin
Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
FAS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0001
source section id
NCT01041404-om-0001
source outcome index
1
endpoint
Progression-Free Survival (PFS) - Percentage of Participants With an Event
endpoint definition
PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.
time origin
BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0002
source section id
NCT01041404-om-0002
source outcome index
2
endpoint
Progression-Free Survival - Time to Event
endpoint definition
The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.
time origin
BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0003
source section id
NCT01041404-om-0003
source outcome index
3
endpoint
Time to Progression (TTP) - Percentage of Participants With an Event
endpoint definition
TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.
time origin
BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0004
source section id
NCT01041404-om-0004
source outcome index
4
endpoint
Time to Progression - Time to Event
endpoint definition
The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.
time origin
BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0005
source section id
NCT01041404-om-0005
source outcome index
5
endpoint
Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)
endpoint definition
For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.
time origin
BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
FAS
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0000
arm key
OG000
arm label
Fluoropyrimidine/Cisplatin (FP)
regimen
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
analyzed count
290
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0000
arm key
OG001
arm label
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
regimen
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
analyzed count
294
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0001
arm key
OG000
arm label
Fluoropyrimidine/Cisplatin (FP)
regimen
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
analyzed count
290
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0001
arm key
OG001
arm label
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
regimen
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
analyzed count
294
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0002
arm key
OG000
arm label
Fluoropyrimidine, Cisplatin
regimen
Participants received fluorouracil 800 mg/m\^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles. Participants also received cisplatin 80 mg/m\^2, IV, on Day 1 of cycle every 3 weeks for 6 cycles; as well as, capecitabine 1000 mg/m\^2, PO, twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
analyzed count
290
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0002
arm key
OG001
arm label
Trastuzumab, Fluoropyrimidine, Cisplatin
regimen
Participants received an initial loading dose of trastuzumab 8 mg/kg, IV, on Day 1 of cycle, followed by 6 mg/kg, IV, every 3 weeks until disease progression. Participants also received fluorouracil 800 mg/m\^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles; cisplatin 80 mg/m\^2 IV on Day 1 of cycle every 3 weeks for 6 cycles; and capecitabine 1000 mg/m\^2 PO twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
analyzed count
294
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0003
arm key
OG000
arm label
Fluoropyrimidine/Cisplatin (FP)
regimen
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
analyzed count
290
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0003
arm key
OG001
arm label
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
regimen
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
analyzed count
294
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0004
arm key
OG000
arm label
Fluoropyrimidine/Cisplatin (FP)
regimen
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
analyzed count
290
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0004
arm key
OG001
arm label
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
regimen
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
analyzed count
294
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0005
arm key
OG000
arm label
Fluoropyrimidine/Cisplatin (FP)
regimen
Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
analyzed count
290
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
outcome key
om-0005
arm key
OG001
arm label
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
regimen
Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
analyzed count
294
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01041404-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
harm key
EG000
source section id
NCT01041404-ae
event group key
EG000
event group label
Fluoropyrimidine/Cisplatin (FP)
serious affected
81
serious at risk
290
other affected
279
other at risk
290
frequency threshold
5
collection period
Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
event definition
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
harm key
EG001
source section id
NCT01041404-ae
event group key
EG001
event group label
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
serious affected
106
serious at risk
294
other affected
286
other at risk
294
frequency threshold
5
collection period
Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
event definition
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
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

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
qol key
qol-0010
source section id
NCT01041404-om-0010
source outcome index
10
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores
measure definition
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.
time frame
BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score equals (=) better
population note
FAS; n (number) = number of participants assessed for a specific parameter at a given visit.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ontruzant-6c14b147
nct id
NCT01041404
qol key
qol-0011
source section id
NCT01041404-om-0011
source outcome index
11
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
measure definition
The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.
time frame
BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score=better
population note
FAS; n = number of participants assessed for a specific parameter at a given visit.
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