TriangleNCT00867113 · STUDY IN CONTEXT
Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)
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
Recurrence-free survival assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event).
Recurrence-free survival (RFS) assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event). RFS estimates were summarized using the Kaplan-Meier product-limit method (Kaplan 1958). Censoring rules for RFS with the earliest occurring rule used in the analysis: subjects without objective recurrence of disease who were alive at the time of their discontinuation from study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment and subjects recording antineoplastic therapy during the study were censored on the date of the therapy initiated
Overall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.
Overall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.
Reported safety
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-gastrointestinal-stromal-tumors
- nct id
- NCT00867113
- trial label
- Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)
- 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
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT00867113
- outcome key
- om-0000
- source section id
- NCT00867113-om-0000
- source outcome index
- 0
- endpoint
- Recurrence-free Survival up to 60 Months
- endpoint definition
- Recurrence-free survival assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event).
- time origin
- Baseline up to 60 months
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT00867113
- outcome key
- om-0001
- source section id
- NCT00867113-om-0001
- source outcome index
- 1
- endpoint
- Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months
- endpoint definition
- Recurrence-free survival (RFS) assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event). RFS estimates were summarized using the Kaplan-Meier product-limit method (Kaplan 1958). Censoring rules for RFS with the earliest occurring rule used in the analysis: subjects without objective recurrence of disease who were alive at the time of their discontinuation from study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment and subjects recording antineoplastic therapy during the study were censored on the date of the therapy initiated
- time origin
- Baseline up to 60 months
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT00867113
- outcome key
- om-0002
- source section id
- NCT00867113-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival (OS) at 60 Months
- endpoint definition
- Overall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.
- time origin
- Baseline up to approximately 60 months
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT00867113
- outcome key
- om-0003
- source section id
- NCT00867113-om-0003
- source outcome index
- 3
- endpoint
- Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months
- endpoint definition
- Overall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.
- time origin
- Baseline up to appoximately 60 months
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT00867113
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Imatinib
- regimen
- All subjects received in tablet form imatinib (STI571) 400 mg once daily.
- analyzed count
- 91
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00867113-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT00867113
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Imatinib
- regimen
- All subjects received in tablet form imatinib (STI571) 400 mg once daily.
- analyzed count
- 91
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00867113-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT00867113
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Imatinib
- regimen
- All subjects received in tablet form imatinib (STI571) 400 mg once daily.
- analyzed count
- 91
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00867113-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT00867113
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Imatinib
- regimen
- All subjects received in tablet form imatinib (STI571) 400 mg once daily.
- analyzed count
- 91
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00867113-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastrointestinal-stromal-tumors
- nct id
- NCT00867113
- harm key
- EG000
- source section id
- NCT00867113-ae
- event group key
- EG000
- event group label
- Imatinib
- serious affected
- 28
- serious at risk
- 91
- other affected
- 91
- other at risk
- 91
- frequency threshold
- 5
- collection period
- Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 7 years
- 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