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← Gastrointestinal Stromal Tumors

NCT00028002 · STUDY IN CONTEXT

Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor

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

Kaplan-Meier estimate of disease progression rate. Disease progression is determined by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf

All eligible patients.

→

secondary · POSTED

The percentage of patients who achieved a complete, partial or stable response prior to surgery as assessed by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf.

Eligible patients who started study treatment

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secondary · POSTED

Highest grade toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity, using Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.

All eligible patients who started study treatment (for pre-surgery), and who additionally had surgery (post-surgery)

→

secondary · POSTED

evaluate FDG-PET as a non-invasive functional imaging tool to assess in situ tumor metabolism (as measured by the Standardized Uptake Values of FDG in the tumor) prior to and during the administration of IM. %change in SUVmax \<1 indicate decreased tumor metabolism while values \>1 indicated an increase in tumor metabolism. Metabolic response by 18F-FDG PET was determined in accordance with the criteria of the European Organization for Research and Treatment of Cancer EORTC), with increases or decreases of more than 25% in SUVmax defining progressive metabolic disease (PMD) and partial metabolic response (PMR), respectively, and new lesions defining PMD.

Source null

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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 · FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy

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-gastrointestinal-stromal-tumors
nct id
NCT00028002
qol key
qol-0003
source section id
NCT00028002-om-0003
source outcome index
3
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy
measure definition
evaluate FDG-PET as a non-invasive functional imaging tool to assess in situ tumor metabolism (as measured by the Standardized Uptake Values of FDG in the tumor) prior to and during the administration of IM. %change in SUVmax \<1 indicate decreased tumor metabolism while values \>1 indicated an increase in tumor metabolism. Metabolic response by 18F-FDG PET was determined in accordance with the criteria of the European Organization for Research and Treatment of Cancer EORTC), with increases or decreases of more than 25% in SUVmax defining progressive metabolic disease (PMD) and partial metabolic response (PMR), respectively, and new lesions defining PMD.
time frame
change from baseline to 1 week post therapy
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
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-gastrointestinal-stromal-tumors
nct id
NCT00028002
trial label
Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor
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
4
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00028002
    outcome key
    om-0000
    source section id
    NCT00028002-om-0000
    source outcome index
    0
    endpoint
    Rate of Disease Progression at 2 Years
    endpoint definition
    Kaplan-Meier estimate of disease progression rate. Disease progression is determined by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf
    time origin
    From registration to two years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients.
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00028002
    outcome key
    om-0001
    source section id
    NCT00028002-om-0001
    source outcome index
    1
    endpoint
    Rates of Objective Response (Complete, Partial, and Stable)
    endpoint definition
    The percentage of patients who achieved a complete, partial or stable response prior to surgery as assessed by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf.
    time origin
    Pretreatment and prior to surgery (at 4-10 weeks, based on surgery timing)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients who started study treatment
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00028002
    outcome key
    om-0002
    source section id
    NCT00028002-om-0002
    source outcome index
    2
    endpoint
    Percentage of Patients With Major Toxicity (Toxicity Grade ≥ 3)
    endpoint definition
    Highest grade toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity, using Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.
    time origin
    Analysis occurs after all patients have been on study for at least 2 years. Measured from start of treatment to end of follow-up, to a maximum of 4.95 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients who started study treatment (for pre-surgery), and who additionally had surgery (post-surgery)
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00028002
    outcome key
    om-0003
    source section id
    NCT00028002-om-0003
    source outcome index
    3
    endpoint
    FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy
    endpoint definition
    evaluate FDG-PET as a non-invasive functional imaging tool to assess in situ tumor metabolism (as measured by the Standardized Uptake Values of FDG in the tumor) prior to and during the administration of IM. %change in SUVmax \<1 indicate decreased tumor metabolism while values \>1 indicated an increase in tumor metabolism. Metabolic response by 18F-FDG PET was determined in accordance with the criteria of the European Organization for Research and Treatment of Cancer EORTC), with increases or decreases of more than 25% in SUVmax defining progressive metabolic disease (PMD) and partial metabolic response (PMR), respectively, and new lesions defining PMD.
    time origin
    change from baseline to 1 week post therapy
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00028002
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Imatinib Mesylate
    regimen
    Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00028002-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00028002
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Imatinib Mesylate
    regimen
    Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00028002-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00028002
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Imatinib Mesylate
    regimen
    Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00028002-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00028002
    outcome key
    om-0003
    arm key
    OG000
    arm label
    PET Patricipants
    regimen
    FDG-PET was done at baseline, 1-7 days after IM initiation, in patients with GIST undergoing neoadjuvant IM therapy. Tumor GLUT4 expression by immunohistochemistry (IHC) and mutation analyses were done at baseline and/or surgery. Background-subtracted SUVmax was measured in all lesions and summed; Metabolic Response (MR)based on EORTC criteria was compared to Response Evaluation Criteria in Solid Tumors (RECIST), GLUT4 expression, and KIT/PDGFRA mutation status.
    analyzed count
    44
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00028002-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT00028002
    harm key
    EG000
    source section id
    NCT00028002-ae
    event group key
    EG000
    event group label
    Imatinib Mesylate
    serious affected
    22
    serious at risk
    52
    other affected
    52
    other at risk
    52
    frequency threshold
    0
    collection period
    Adverse event (AE) information is collected Weeks 1, 4, 8, Months 3,8,9, then every 3 months until 2 years, then every 6 months until 5 years, then annually. (SAE = Serious Adverse Event).
    event definition
    Per the protocol, toxicity data was collected via CTC 2.0 then mapped to CTCAE 4.0 to report here. Subjects experiencing more than one of a given adverse event (AE) are counted only once for that AE.
    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-gastrointestinal-stromal-tumors
    nct id
    NCT00028002
    qol key
    qol-0003
    source section id
    NCT00028002-om-0003
    source outcome index
    3
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy
    measure definition
    evaluate FDG-PET as a non-invasive functional imaging tool to assess in situ tumor metabolism (as measured by the Standardized Uptake Values of FDG in the tumor) prior to and during the administration of IM. %change in SUVmax \<1 indicate decreased tumor metabolism while values \>1 indicated an increase in tumor metabolism. Metabolic response by 18F-FDG PET was determined in accordance with the criteria of the European Organization for Research and Treatment of Cancer EORTC), with increases or decreases of more than 25% in SUVmax defining progressive metabolic disease (PMD) and partial metabolic response (PMR), respectively, and new lesions defining PMD.
    time frame
    change from baseline to 1 week post therapy
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    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