TriangleNCT00087438 · STUDY IN CONTEXT
Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung 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
Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method.
Specified adverse events are defined as any treatment-related adverse events that are grade 4, grade 5, or any of the following treatment-related grade 3 adverse events: * Gastrointestinal: dysphagia, esophagitis, esophageal stricture, esophageal ulceration; * Cardiac: pericarditis, pericardial effusion, cardiomyopathy, ventricular dysfunction; * Neurologic: myelitis, neuropathy (cranial and motor) * Hemorrhage: pulmonary or upper respiratory * Pulmonary: decline in pulmonary function as measured by pulmonary function tests, pneumonitis, pulmonary fibrosis, hypoxemia, pleural effusion. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Local failure is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Time to local recurrence is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local recurrence (censored).
Regional recurrence is defined as hilar, mediastinal, and supraclavicular nodal failure.Time to regional recurrence is defined as time from start of treatment to the date of first regional recurrence, last known follow-up (censored), or death without regional recurrence (competing risk). Rates are estimated using the cumulative incidence method.
Disseminated recurrence is defined as uninvolved lobe failures and failures beyond the lungs and regional lymph nodes. Time to disseminated recurrence is defined as time from start of treatment to the the date of disseminated recurrence, last known follow-up (censored), or death without disseminated recurrence (competing risk). Rates are estimated using the cumulative incidence method.
Disease is defined as local or regional progression or development of distant metastases. Disease-free survival time is defined as time from start of treatment to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.
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-malignant-lung-neoplasm
- nct id
- NCT00087438
- trial label
- Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung 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
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0000
- source section id
- NCT00087438-om-0000
- source outcome index
- 0
- endpoint
- Local Control at 2 Years
- endpoint definition
- Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method.
- time origin
- From the start of treatment to 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who started protocol treatment.
- 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-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0001
- source section id
- NCT00087438-om-0001
- source outcome index
- 1
- endpoint
- Proportion of Subjects With Specified Adverse Events
- endpoint definition
- Specified adverse events are defined as any treatment-related adverse events that are grade 4, grade 5, or any of the following treatment-related grade 3 adverse events: * Gastrointestinal: dysphagia, esophagitis, esophageal stricture, esophageal ulceration; * Cardiac: pericarditis, pericardial effusion, cardiomyopathy, ventricular dysfunction; * Neurologic: myelitis, neuropathy (cranial and motor) * Hemorrhage: pulmonary or upper respiratory * Pulmonary: decline in pulmonary function as measured by pulmonary function tests, pneumonitis, pulmonary fibrosis, hypoxemia, pleural effusion. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
- time origin
- From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 2 years. Maximum follow-up at time of analysis was 4.2 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who started study treatment
- 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-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0002
- source section id
- NCT00087438-om-0002
- source outcome index
- 2
- endpoint
- Rate of Local Recurrence at 2 Years
- endpoint definition
- Local failure is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Time to local recurrence is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local recurrence (censored).
- time origin
- From the start of treatment to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients
- 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-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0003
- source section id
- NCT00087438-om-0003
- source outcome index
- 3
- endpoint
- Rate of Regional Recurrence at 2 Years
- endpoint definition
- Regional recurrence is defined as hilar, mediastinal, and supraclavicular nodal failure.Time to regional recurrence is defined as time from start of treatment to the date of first regional recurrence, last known follow-up (censored), or death without regional recurrence (competing risk). Rates are estimated using the cumulative incidence method.
- time origin
- From the start of treatment to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients
- 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-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0004
- source section id
- NCT00087438-om-0004
- source outcome index
- 4
- endpoint
- Rate of Disseminated Recurrence at 2 Years
- endpoint definition
- Disseminated recurrence is defined as uninvolved lobe failures and failures beyond the lungs and regional lymph nodes. Time to disseminated recurrence is defined as time from start of treatment to the the date of disseminated recurrence, last known follow-up (censored), or death without disseminated recurrence (competing risk). Rates are estimated using the cumulative incidence method.
- time origin
- From the start of treatment to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients
- 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-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0005
- source section id
- NCT00087438-om-0005
- source outcome index
- 5
- endpoint
- Rate of Disease-free Survival at 2 Years
- endpoint definition
- Disease is defined as local or regional progression or development of distant metastases. Disease-free survival time is defined as time from start of treatment to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.
- time origin
- From the start of treatment to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients
- 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-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Stereotactic Body Radiation Therapy (SBRT)
- regimen
- 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087438-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Stereotactic Body Radiation Therapy (SBRT)
- regimen
- 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087438-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Stereotactic Body Radiation Therapy (SBRT)
- regimen
- 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087438-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Stereotactic Body Radiation Therapy (SBRT)
- regimen
- 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087438-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Stereotactic Body Radiation Therapy (SBRT)
- regimen
- 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087438-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00087438
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Stereotactic Body Radiation Therapy (SBRT)
- regimen
- 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00087438-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00087438
- harm key
- EG000
- source section id
- NCT00087438-ae
- event group key
- EG000
- event group label
- Stereotactic Body Radiation Therapy (SBRT)
- serious affected
- 11
- serious at risk
- 55
- other affected
- 49
- other at risk
- 55
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
- 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