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NCT00052910 · STUDY IN CONTEXT

Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer

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. 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

Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

Source null

→

secondary · POSTED

Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.

Source null

→

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer
nct id
NCT00052910
trial label
Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer
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.
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
2
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer
    nct id
    NCT00052910
    outcome key
    om-0000
    source section id
    NCT00052910-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
    time origin
    From study enrollment until death from any cause; up to 3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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
    nct id
    NCT00052910
    outcome key
    om-0001
    source section id
    NCT00052910-om-0001
    source outcome index
    1
    endpoint
    Disease Free Survival
    endpoint definition
    Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.
    time origin
    From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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
    nct id
    NCT00052910
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (5-FU/LV)
    regimen
    Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
    analyzed count
    280
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00052910-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer
    nct id
    NCT00052910
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II (ECF)
    regimen
    Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
    analyzed count
    266
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00052910-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer
    nct id
    NCT00052910
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (5-FU/LV)
    regimen
    Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
    analyzed count
    280
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00052910-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer
    nct id
    NCT00052910
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II (ECF)
    regimen
    Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
    analyzed count
    266
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00052910-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer
    nct id
    NCT00052910
    harm key
    EG000
    source section id
    NCT00052910-ae
    event group key
    EG000
    event group label
    Arm I (5-FU/LV)
    serious affected
    62
    serious at risk
    272
    other affected
    258
    other at risk
    272
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    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
    nct id
    NCT00052910
    harm key
    EG001
    source section id
    NCT00052910-ae
    event group key
    EG001
    event group label
    Arm II (ECF)
    serious affected
    42
    serious at risk
    251
    other affected
    234
    other at risk
    251
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    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
    setting source links

      Preserved source evidence · Not medical advice