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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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Rationale: Surgery remains the standard of care for stage 1 (T1-2a N0)non-small cell lung cancer. Stereotactic body radiation therapy is a newer radiation treatment that gives fewer but higher and possibly more effective doses of radiation than standard radiation. This technique may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic body radiation therapy is more effective than surgery in treating non-small cell lung cancer.
Purpose: The primary aim of this randomized phase II trial is to determine if the efficacy of SBRT is comparable to that of standard surgical interventions for patients with T1N0 non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Other | R0 resection (radical resection) with nodal dissection or sampling (RODS). |
|
| Stereotactic Body Radiation Therapy (SBRT) | Experimental | Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | Daily fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Alive Without Local-regional Failure at Two Years (Local-regional Tumor Control) | Local-regional failure (LRF) is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum (N1 nodal region), mediastinum (N2-N3 nodes), ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, confirmed by positron PET/CT, within same lobe, hilum (N1 nodes), mediastinum (N2-N3 nodes), or ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of original planning target volume (PTV). Local-regional control time is defined as time from randomization to the date of first LRF, death, or last known follow-up (censored), whichever occurred first. Rates are estimated using the Kaplan-Meier method. | From date of randomization to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (Percentage of Participants Alive) | Overall survival rates are estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Two-year rates are provided. | From date of randomization to date of death or last follow-up. Maximum follow-up was 7.0 years. |
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Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of Stage I NSCLC [American Joint Committee on Cancer (AJCC), 7th ed.], T1N0M0; note: T1N0 disease must be confirmed by FDG-PET/CT. (FDG = 18F-fluorodeoxyglucose; PET = positron emission tomography; CT = Computed Tomography)
Biopsy confirmation of diagnosis is strongly recommended but not required. If the biopsy is attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of biopsy is considered too high, patients may be enrolled if the mass is suspicious for NSCLC based on 2 or more of the following criteria:
The following primary cancer types are eligible: squamous cell carcinoma; adenocarcinoma; large cell carcinoma/ large cell neuroendocrine carcinoma; non-small cell carcinoma not otherwise specified.
Patients with hilar or mediastinal lymph nodes ≤ 1 cm and no abnormal hilar or mediastinal uptake on PET and CT will be considered N0. Mediastinal lymph node biopsy is required for patients with visible nodes: patients with > 1 cm hilar or mediastinal lymph nodes on CT or with nodes appearing as abnormal on PET (including suspicious but nondiagnostic uptake). Such patients will not be eligible unless directed biopsies of all abnormal lymph nodes are negative for cancer or these nodes demonstrate a lack of change during the prior 6 months and thus are considered to be non-malignant.
The patient must be considered a reasonable candidate for surgical resection using a lobectomy or pneumonectomy of the primary tumor within 6 weeks prior to registration, according to the following criteria based on the American College of Chest Physicians guidelines [165]:
Pleural effusion, if present, must be deemed too small to tap under CT guidance and must not be evident on chest x-ray. Pleural effusion that appears on chest x-ray will be permitted only if there is no evidence of malignancy after invasive cytologic assessment.
Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
Zubrod Performance Status 0-1 within 6 weeks prior to registration;
Age ≥ 18;
For women of childbearing potential, a serum or urine pregnancy test must be negative within 72 hours prior to registration;
Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment if assigned to treatment with SBRT.
Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria:
Direct evidence of regional or distant metastases after PET and surgical staging studies, or synchronous primary malignancy or prior invasive malignancy in the past 3 years, with the following exceptions:
Primary tumors >3 cm;
Prior systemic chemotherapy or thoracic surgery involving lobectomy or pneumonectomy;
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Pure bronchioloalveolar carcinoma subtype of non-small cell lung cancer;
Active systemic, pulmonary, or pleural pericardial infection;
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
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| Name | Affiliation | Role |
|---|---|---|
| Feng-Ming (Spring) Kong, MD, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Science | Beijing | 10021 | China | |||
| Shandong Cancer Hospital, Jinan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32736936 | Derived | Elbanna M, Shiue K, Edwards D, Cerra-Franco A, Agrawal N, Hinton J, Mereniuk T, Huang C, Ryan JL, Smith J, Aaron VD, Burney H, Zang Y, Holmes J, Langer M, Zellars R, Lautenschlaeger T. Impact of Lung Parenchymal-Only Failure on Overall Survival in Early-Stage Lung Cancer Patients Treated With Stereotactic Ablative Radiotherapy. Clin Lung Cancer. 2021 May;22(3):e342-e359. doi: 10.1016/j.cllc.2020.05.024. Epub 2020 Jun 2. |
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Of 47 participants registered to the first step of the study, 44 were randomized. Randomization required FDG-PET/CT (FDG = 18F-fluorodeoxyglucose; PET = positron emission tomography; CT = Computed Tomography) staging to confirm T1N0 disease, per American Joint Committee on Cancer (AJCC), 7th edition.
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery | R0 resection (radical resection) with nodal dissection or sampling (RODS). |
| FG001 | Stereotactic Body Radiation Therapy (SBRT) | Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgery | R0 resection (radical resection) with nodal dissection or sampling (RODS). |
| BG001 | Stereotactic Body Radiation Therapy (SBRT) | Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Alive Without Local-regional Failure at Two Years (Local-regional Tumor Control) | Local-regional failure (LRF) is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum (N1 nodal region), mediastinum (N2-N3 nodes), ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, confirmed by positron PET/CT, within same lobe, hilum (N1 nodes), mediastinum (N2-N3 nodes), or ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of original planning target volume (PTV). Local-regional control time is defined as time from randomization to the date of first LRF, death, or last known follow-up (censored), whichever occurred first. Rates are estimated using the Kaplan-Meier method. | Randomized participants with follow-up data | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to two years |
Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgery | R0 resection (radical resection) with nodal dissection or sampling (RODS). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
This study stopped accrual early due to unmet targeted accrual goals with 44 participants randomized out of 72 planned. Statistical testing was not done due to low accrual.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | 2155743208 | seiferheldw@nrgoncology.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2018 | Jan 11, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 6, 2018 | Jan 11, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Surgery | Procedure | Radical resection |
|
| Percentage of Participants With Local-regional Failure (LRF) | LRF rates are estimated using the cumulative incidence method. LRF is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum (N1 nodal region), mediastinum (N2-N3 nodes), ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, confirmed by PET/CT, within same lobe, hilum (N1 nodes), mediastinum (N2-N3 nodes), or ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of original PTV. LRF time is defined as time from randomization to the date of first LRF, last known follow-up (censored), or death without LRF (competing risk), whichever occurred first. Two-year rates are provided. | From date of randomization to the date of first local-regional failure, death, or last known follow-up, whichever occurred first. Maximum follow-up is 7.0 years. |
| Percentage of Participants With Distant Failure | Distant failure rates are estimated using the cumulative incidence method. Distant failure is defined as appearance of tumor within another ipsilateral (non-primary) lobe ≥ 2 cm from the original planning target volume (PTV) or distant metastasis, including appearance of tumor deposits characteristic of NSCLC metastasis (chest wall other than incision sites, mediastinal structures/diaphragm, malignant pleural/pericardial effusion), contralateral lung and/or other distant sites. Time to distant failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Two-year rates are provided. | From date of randomization to date of first distant failure, death, or last known follow-up, whichever occurred first. Maximum follow-up was 7.0 years. |
| Percentage of Participants Alive Without Disease [Disease-free Survival (DFS)] | Failure rates are estimated using the Kaplan-Meier method, where failure is defined as LRF, DF, or death from any cause. LRF is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at the resection site, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per RECIST criteria, confirmed by PET/CT, within same lobe, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of original PTV. DF is defined as tumor within a non-primary lobe ≥ 2 cm from the original planning target volume or distant metastasis. Failure time is defined as time from randomization to the date of first failure or last known follow-up (censored), whichever occurred first. Two-year rates are provided. | From date of randomization to the date of first failure, death, or last known follow-up, whichever occurred first. Maximum follow-up is 7.0 years. |
| Number of Participants by Failure Site | Local-regional failure (LRF) is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum, mediastinum, ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per RECIST criteria, confirmed by PET/CT, within same lobe, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of original planning target volume (PTV). Distant failure is defined as tumor within a non-primary lobe ≥ 2 cm from the original planning target volume or distant metastasis, including tumor deposits characteristic NSCLC metastasis (chest wall other than incision sites, mediastinal structures/diaphragm, malignant pleural/pericardial effusion), contralateral lung and/or other distant sites. | From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years. |
| Best PET Tumor Response | PET Tumor Response of Irradiated Target Lesions is defined as
| From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years. |
| Number of Participants by Highest Grade Adverse Event Reported | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | From date of randomization to the date of last known follow-up. Maximum follow-up time was 7.0 years. |
| Number of Participants With Surgical and Radiation Treatment Credentialing Completed and Documented Before Enrollment (Trial Feasibility) | baseline |
| Number of Eligible Participants (Trial Feasibility) | Goal: 95% of participants retain eligibility status (meet all eligibility criteria) after central review by headquarters staff. | Baseline |
| Number of Participants With Baseline Forms Completed and Provided Within 30 Days of Randomization (Trial Feasibility) | Baseline |
| Number of Participants Lost to Follow-up (Trial Feasibility) | Goal: < 3% of participants lost to follow-up. | From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years. |
| Shangdong |
| 250117 |
| China |
| Shanghai Cancer Center/Fudan University | Shanghai | 200032 | China |
| Zhejiang Cancer Hospital, Hangzhou | Zhejiang | 310022 | China |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Zubrod performance status | 0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, <50% in bed during the day; 3 = Symptomatic, >50% in bed, but not bedbound; 4 = Bedbound; 5 = Death | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| Forced expiratory volume in one second (FEV1) | Median | Full Range | liters/second |
|
| Percent predicted FEV1 | Percentage of the predicted normal value based on age, gender, height, and ethnicity. Higher value indicates better condition. | Randomized participants with data | Median | Full Range | percentage |
|
| Forced vital capacity (FVC) | Median | Full Range | liters/second |
|
| Percent predicted FVC | Percentage of the predicted normal value based on age, gender, height, and ethnicity. Higher value indicates better condition. | Randomized participants with data | Median | Full Range | percentage |
|
| Percent predicted Diffusing capacity for carbon monoxide (DLCO) | Percentage of the predicted normal value based on age, gender, height, and ethnicity. Higher value indicates better condition. | Randomized participants with data | Median | Full Range | percentage |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Surgery | R0 resection (radical resection) with nodal dissection or sampling (RODS). |
| OG001 | Stereotactic Body Radiation Therapy (SBRT) | Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days. |
|
|
| Secondary | Overall Survival (Percentage of Participants Alive) | Overall survival rates are estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Two-year rates are provided. | Randomized participants with follow-up data | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to date of death or last follow-up. Maximum follow-up was 7.0 years. |
|
|
|
| Secondary | Percentage of Participants With Local-regional Failure (LRF) | LRF rates are estimated using the cumulative incidence method. LRF is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum (N1 nodal region), mediastinum (N2-N3 nodes), ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, confirmed by PET/CT, within same lobe, hilum (N1 nodes), mediastinum (N2-N3 nodes), or ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of original PTV. LRF time is defined as time from randomization to the date of first LRF, last known follow-up (censored), or death without LRF (competing risk), whichever occurred first. Two-year rates are provided. | Randomized participants with follow-up data | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to the date of first local-regional failure, death, or last known follow-up, whichever occurred first. Maximum follow-up is 7.0 years. |
|
|
|
| Secondary | Percentage of Participants With Distant Failure | Distant failure rates are estimated using the cumulative incidence method. Distant failure is defined as appearance of tumor within another ipsilateral (non-primary) lobe ≥ 2 cm from the original planning target volume (PTV) or distant metastasis, including appearance of tumor deposits characteristic of NSCLC metastasis (chest wall other than incision sites, mediastinal structures/diaphragm, malignant pleural/pericardial effusion), contralateral lung and/or other distant sites. Time to distant failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Two-year rates are provided. | Randomized participants with follow-up data | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to date of first distant failure, death, or last known follow-up, whichever occurred first. Maximum follow-up was 7.0 years. |
|
|
|
| Secondary | Percentage of Participants Alive Without Disease [Disease-free Survival (DFS)] | Failure rates are estimated using the Kaplan-Meier method, where failure is defined as LRF, DF, or death from any cause. LRF is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at the resection site, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per RECIST criteria, confirmed by PET/CT, within same lobe, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of original PTV. DF is defined as tumor within a non-primary lobe ≥ 2 cm from the original planning target volume or distant metastasis. Failure time is defined as time from randomization to the date of first failure or last known follow-up (censored), whichever occurred first. Two-year rates are provided. | Randomized participants with follow-up data | Posted | Number | 95% Confidence Interval | percentage of participants | From date of randomization to the date of first failure, death, or last known follow-up, whichever occurred first. Maximum follow-up is 7.0 years. |
|
|
|
| Secondary | Number of Participants by Failure Site | Local-regional failure (LRF) is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum, mediastinum, ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per RECIST criteria, confirmed by PET/CT, within same lobe, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of original planning target volume (PTV). Distant failure is defined as tumor within a non-primary lobe ≥ 2 cm from the original planning target volume or distant metastasis, including tumor deposits characteristic NSCLC metastasis (chest wall other than incision sites, mediastinal structures/diaphragm, malignant pleural/pericardial effusion), contralateral lung and/or other distant sites. | Randomized participants with follow-up data | Posted | Count of Participants | Participants | From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years. |
|
|
|
| Secondary | Best PET Tumor Response | PET Tumor Response of Irradiated Target Lesions is defined as
| Randomized participants with follow-up PET scan | Posted | Count of Participants | Participants | From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years. |
|
|
|
| Secondary | Number of Participants by Highest Grade Adverse Event Reported | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | Randomized participants who started protocol treatment | Posted | Count of Participants | Participants | From date of randomization to the date of last known follow-up. Maximum follow-up time was 7.0 years. |
|
|
|
| Secondary | Number of Participants With Surgical and Radiation Treatment Credentialing Completed and Documented Before Enrollment (Trial Feasibility) | Randomized participants | Posted | Count of Participants | Participants | baseline |
|
|
|
| Secondary | Number of Eligible Participants (Trial Feasibility) | Goal: 95% of participants retain eligibility status (meet all eligibility criteria) after central review by headquarters staff. | Randomized participants | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants With Baseline Forms Completed and Provided Within 30 Days of Randomization (Trial Feasibility) | Randomized participants | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants Lost to Follow-up (Trial Feasibility) | Goal: < 3% of participants lost to follow-up. | Randomized participants | Posted | Count of Participants | Participants | From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years. |
|
|
|
| 5 |
| 21 |
| 0 |
| 16 |
| 13 |
| 16 |
| EG001 | Stereotactic Body Radiation Therapy (SBRT) | Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days. | 5 | 21 | 0 | 19 | 15 | 19 |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| CPK increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Cardiac troponin T increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Cholesterol high | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Metabolism and nutrition disorders - Other | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hemoglobinuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 |
| Investigative Techniques |
| 60-69 |
|
| 70-79 |
|
| ≥80 |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Non-small cell caarcinoma, NOS |
|
| Progressive Metabolic Disease |
|
| Stable Metabolic Disease |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|