TriangleNCT00750269 · STUDY IN CONTEXT
Stereotactic Body Radiation Therapy in Treating Patients With Stage I 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
Maximum tolerated dose (MTD) defined as dose most closely associated with a 20% probability of experiencing a toxicity \<= 1 year from start of SBRT from following dose-limiting toxicities: Gr 3-5 Cardiac: Pericardial effusion, Pericarditis, Restrictive cardiomyopathy; Gr 4-5 GI: Dysphagia, Esophagitis, Esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage; Gr 3-5 Nervous System Disorders: Brachial plexopathy, Recurrent laryngeal nerve palsy, Myelitis; Gr 3-5 Respiratory: Atelectasis (gr 4-5 only), Bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, Bronchial/pulmonary/bronchopleural/tracheal fistula, Hypoxia (provided gr 3 is worse than baseline), Bronchial/tracheal obstruction, Pleural effusion, Pneumonitis, Pulmonary fibrosis; Changes in Pulmonary Function Tests per SBRT Pulmonary Toxicity Scale, Gr 3-5: FEV1 decline, FVC decline; Any Gr 5 adverse event attributed to treatment. Dose level was determined by time-to-event continual reassessment method (TITE-CRM).
Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.
Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
An event for overall survival is death due to any cause. Overall survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
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-lung-carcinoma
- nct id
- NCT00750269
- trial label
- Stereotactic Body Radiation Therapy in Treating Patients With Stage I 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
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0000
- source section id
- NCT00750269-om-0000
- source outcome index
- 0
- endpoint
- (Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0
- endpoint definition
- Maximum tolerated dose (MTD) defined as dose most closely associated with a 20% probability of experiencing a toxicity \<= 1 year from start of SBRT from following dose-limiting toxicities: Gr 3-5 Cardiac: Pericardial effusion, Pericarditis, Restrictive cardiomyopathy; Gr 4-5 GI: Dysphagia, Esophagitis, Esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage; Gr 3-5 Nervous System Disorders: Brachial plexopathy, Recurrent laryngeal nerve palsy, Myelitis; Gr 3-5 Respiratory: Atelectasis (gr 4-5 only), Bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, Bronchial/pulmonary/bronchopleural/tracheal fistula, Hypoxia (provided gr 3 is worse than baseline), Bronchial/tracheal obstruction, Pleural effusion, Pneumonitis, Pulmonary fibrosis; Changes in Pulmonary Function Tests per SBRT Pulmonary Toxicity Scale, Gr 3-5: FEV1 decline, FVC decline; Any Gr 5 adverse event attributed to treatment. Dose level was determined by time-to-event continual reassessment method (TITE-CRM).
- time origin
- From start of SBRT to 1 year
- analysis role
- primary
- 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-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0001
- source section id
- NCT00750269-om-0001
- source outcome index
- 1
- endpoint
- (Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)
- endpoint definition
- Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.
- time origin
- From start of SBRT to 2 years.
- analysis role
- primary
- 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-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0002
- source section id
- NCT00750269-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival
- endpoint definition
- Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
- time origin
- From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
- 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-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0003
- source section id
- NCT00750269-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival
- endpoint definition
- An event for overall survival is death due to any cause. Overall survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.
- time origin
- From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
- 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-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0004
- source section id
- NCT00750269-om-0004
- source outcome index
- 4
- endpoint
- Local Progression
- endpoint definition
- Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
- time origin
- From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
- 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-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0005
- source section id
- NCT00750269-om-0005
- source outcome index
- 5
- endpoint
- Nodal Progression
- endpoint definition
- Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.
- time origin
- From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0000
- arm key
- OG000
- arm label
- All Participants
- regimen
- All Participants
- analyzed count
- 100
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Level 8: 11.5 Gy/FX
- regimen
- SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Level 9: 12.0 Gy/FX
- regimen
- SBRT 60.0 Gy SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy
- analyzed count
- 33
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Level 5: 10.0 Gy/FX
- regimen
- SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Level 6: 10.5 Gy/FX
- regimen
- SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Level 7: 11.0 Gy/FX
- regimen
- SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Level 8: 11.5 Gy/FX
- regimen
- SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0002#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0002
- arm key
- OG004
- arm label
- Level 9: 12.0 Gy/FX
- regimen
- SBRT 60.0 Gy SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy
- analyzed count
- 33
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0002#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Level 5: 10.0 Gy/FX
- regimen
- SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Level 6: 10.5 Gy/FX
- regimen
- SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Level 7: 11.0 Gy/FX
- regimen
- SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- outcome key
- om-0003
- arm key
- OG003
- arm label
- Level 8: 11.5 Gy/FX
- regimen
- SBRT 57.5 Gy SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00750269-om-0003#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- harm key
- EG000
- source section id
- NCT00750269-ae
- event group key
- EG000
- event group label
- Level 5: 10.0 Gy/FX
- serious affected
- 1
- serious at risk
- 8
- other affected
- 7
- other at risk
- 8
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Patients 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- harm key
- EG001
- source section id
- NCT00750269-ae
- event group key
- EG001
- event group label
- Level 6: 10.5 Gy/FX
- serious affected
- 0
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Patients 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- harm key
- EG002
- source section id
- NCT00750269-ae
- event group key
- EG002
- event group label
- Level 7: 11.0 Gy/FX
- serious affected
- 2
- serious at risk
- 14
- other affected
- 13
- other at risk
- 14
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Patients 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- harm key
- EG003
- source section id
- NCT00750269-ae
- event group key
- EG003
- event group label
- Level 8: 11.5 Gy/FX
- serious affected
- 9
- serious at risk
- 38
- other affected
- 34
- other at risk
- 38
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Patients 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00750269
- harm key
- EG004
- source section id
- NCT00750269-ae
- event group key
- EG004
- event group label
- Level 9: 12.0 Gy/FX
- serious affected
- 7
- serious at risk
- 33
- other affected
- 27
- other at risk
- 33
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Patients 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