| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000613524 | |||
| NCI-2009-01095 | Registry Identifier | CTRP (Clinical Trials Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks [total of 5 fractions (FX)] in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 2 years, then annually.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Level 1: 8.0 Gy/FX | Experimental | SBRT 40.0 Gy |
|
| Level 2: 8.5 Gy/FX | Experimental | SBRT 42.5 Gy |
|
| Level 3: 9.0 Gy/FX | Experimental | SBRT 45.0 Gy |
|
| Level 4: 9.5 Gy/FX | Experimental | SBRT 47.5 Gy |
|
| Level 5: 10.0 Gy/FX | Experimental | SBRT 50.0 Gy |
|
| Level 6: 10.5 Gy/FX | Experimental | SBRT 52.5 Gy |
|
| Level 7: 11.0 Gy/FX |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT 40.0 Gy | Radiation | SBRT delivered in 5 fractions of 8.0 Gy/fraction over 1.5 to 2 weeks for a total of 40.0 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| (Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 | 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). | From start of SBRT to 1 year |
| (Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD) | 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. | From start of SBRT to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | 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. |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Stage T1-2, N0, M0 disease
Tumor size ≤ 5 cm
Tumor must be within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (i.e., carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right, and left lower lobe bronchi) OR immediately adjacent to the mediastinal or pericardial pleura (PTV touching the pleura)
Hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on positron emission tomography (PET) scan are considered N0
Tumor deemed technically resectable, in the opinion of an experienced thoracic cancer surgeon, with a reasonable possibility of obtaining a gross total resection with negative margins, defined as a potentially curative resection (PCR)
Patient deemed "medically inoperable" due to severe underlying physiological medical problems that would prohibit a PCR, including any of the following:
Measurable disease as documented by CT scan or whole-body PET scan within the past 8 weeks
Pleural effusion allowed provided it is deemed too small to tap under CT guidance and is not evident on chest x-ray
PATIENT CHARACTERISTICS:
Zubrod performance status 0-2
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 60 days after completion of study therapy
No other invasive malignancy within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
PRIOR CONCURRENT THERAPY:
No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
No prior chemotherapy for the study cancer
No other concurrent local therapy (including standard-fractionated radiotherapy and/or surgery) or systemic therapy (including standard chemotherapy or biologic targeted agents) specifically intended as treatment for study cancer
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Bezjak, MD, MSC, FRCPC | Princess Margaret Hospital, Canada | Principal Investigator |
| Jeffrey Bradley, MD | Mallinckrodt Institute of Radiology at Washington University Medical Center | Study Chair |
| Laurie E. Gaspar, MD, MBA | University of Colorado, Denver | Study Chair |
| Robert D. Timmerman, MD | University of Texas | Study Chair |
| Elizabeth Gore, MD | Medical College of Wisconsin | Study Chair |
| Feng-Ming Phoenix Konb, MD, PhD | Georgia Regents University Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Center for Cancer Care - Peoria | Peoria | Arizona | 85381 | United States | ||
| Mayo Clinic Scottsdale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30943123 | Derived | Bezjak A, Paulus R, Gaspar LE, Timmerman RD, Straube WL, Ryan WF, Garces YI, Pu AT, Singh AK, Videtic GM, McGarry RC, Iyengar P, Pantarotto JR, Urbanic JJ, Sun AY, Daly ME, Grills IS, Sperduto P, Normolle DP, Bradley JD, Choy H. Safety and Efficacy of a Five-Fraction Stereotactic Body Radiotherapy Schedule for Centrally Located Non-Small-Cell Lung Cancer: NRG Oncology/RTOG 0813 Trial. J Clin Oncol. 2019 May 20;37(15):1316-1325. doi: 10.1200/JCO.18.00622. Epub 2019 Apr 3. | |
| 26104945 |
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This study was designed to start at dose level 5. Dose levels 1-4 were in place only to be used if the regimen in general proved too toxic and lower dose levels were needed. No patients were accrued to levels 1-4.
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| ID | Title | Description |
|---|---|---|
| FG000 | Level 5: 10.0 Gy/FX | SBRT 50.0 Gy SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy |
| FG001 | Level 6: 10.5 Gy/FX | SBRT 52.5 Gy SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Experimental |
SBRT 55.0 Gy |
|
| Level 8: 11.5 Gy/FX | Experimental | SBRT 57.5 Gy |
|
| Level 9: 12.0 Gy/FX | Experimental | SBRT 60.0 Gy |
|
| SBRT 42.5 Gy | Radiation | SBRT delivered in 5 fractions of 8.5 Gy/fraction over 1.5 to 2 weeks for a total of 42.5 Gy |
|
|
| SBRT 45.0 Gy | Radiation | SBRT delivered in 5 fractions of 9.0 Gy/fraction over 1.5 to 2 weeks for a total of 45.0 Gy |
|
|
| SBRT 47.5 Gy | Radiation | SBRT delivered in 5 fractions of 9.5 Gy/fraction over 1.5 to 2 weeks for a total of 47.5 Gy |
|
|
| SBRT 50.0 Gy | Radiation | SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy |
|
|
| SBRT 52.5 Gy | Radiation | SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy |
|
|
| SBRT 55.0 Gy | Radiation | SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy |
|
|
| SBRT 57.5 Gy | Radiation | SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy |
|
|
| SBRT 60.0 Gy | Radiation | SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy |
|
|
| 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. |
| Overall Survival | 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. | 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. |
| Local Progression | 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. | From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months. |
| Nodal Progression | 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. | 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. |
| Distant Metastases | Distant metastases is defined as the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer. Distant metastases progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested. | From randomization to date of death, distant 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. |
| Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0 | Rate of patients developing any treatment-related toxicity during the first year following the start of SBRT that is not among the types considered as a dose-limiting toxicity. | From start of SBRT until 1 year. |
| Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0 | Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT. | From start of treatment to end of follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. |
| Scottsdale |
| Arizona |
| 85259-5499 |
| United States |
| Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank | California | 91505 | United States |
| Radiation Oncology Centers - Cameron Park | Cameron Park | California | 95682 | United States |
| Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael | California | 95608 | United States |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain | Connecticut | 06050 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| M.D. Anderson Cancer Center at Orlando | Orlando | Florida | 32806 | United States |
| OSF St. Francis Medical Center | Peoria | Illinois | 61637 | United States |
| CCOP - Kansas City | Prairie Village | Kansas | 66208 | United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Norton Suburban Hospital | Louisville | Kentucky | 40207 | United States |
| Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | 71315-3198 | United States |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough | Maine | 04074 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| McLaren Cancer Institute | Flint | Michigan | 48532 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| Saint Louis University Cancer Center | St Louis | Missouri | 63110 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Cooper CyberKnife Center | Mount Laurel | New Jersey | 08054 | United States |
| Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta | New Jersey | 07871 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| St. Luke's - Roosevelt Hospital Center - St.Luke's Division | New York | New York | 10025 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | 10032 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1240 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg | Pennsylvania | 18301 | United States |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Frankford Hospital Cancer Center - Torresdale Campus | Philadelphia | Pennsylvania | 19114 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| St. Joseph Cancer Center | Bellingham | Washington | 98225 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin | 53295 | United States |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Derived |
| Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available. |
| FG002 | Level 7: 11.0 Gy/FX | SBRT 55.0 Gy SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy |
| FG003 | Level 8: 11.5 Gy/FX | 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 |
| FG004 | Level 9: 12.0 Gy/FX | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All eligible patients receiving protocol treatment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Level 5: 10.0 Gy/FX | SBRT 50.0 Gy SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy |
| BG001 | Level 6: 10.5 Gy/FX | SBRT 52.5 Gy SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy |
| BG002 | Level 7: 11.0 Gy/FX | SBRT 55.0 Gy SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy |
| BG003 | Level 8: 11.5 Gy/FX | 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 |
| BG004 | Level 9: 12.0 Gy/FX | 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 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | (Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 | 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). | All eligible patients who started study treatment | Posted | Number | Gy/FX | From start of SBRT to 1 year |
|
|
| ||||||||||||||||||||||||||
| Primary | (Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD) | 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. | All eligible patients who started study treatment | Posted | Number | 90% Confidence Interval | percentage of participants | From start of SBRT to 2 years. |
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival | 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. | All eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | 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. | All eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
| |||||||||||||||||||||||||||
| Secondary | Local Progression | 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. | All eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months. |
| |||||||||||||||||||||||||||
| Secondary | Nodal Progression | 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. | All eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of patients | 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. |
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| Secondary | Distant Metastases | Distant metastases is defined as the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer. Distant metastases progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested. | All eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to date of death, distant 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. |
| |||||||||||||||||||||||||||
| Secondary | Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0 | Rate of patients developing any treatment-related toxicity during the first year following the start of SBRT that is not among the types considered as a dose-limiting toxicity. | All eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From start of SBRT until 1 year. |
| |||||||||||||||||||||||||||
| Secondary | Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0 | Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT. | All eligible patients who started study treatment who were observed more than 1 year after start of SBRT | Posted | Number | 95% Confidence Interval | percentage of participants | From start of treatment to end of follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study. |
|
Not provided
Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Level 5: 10.0 Gy/FX | SBRT 50.0 Gy SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy | 1 | 8 | 7 | 8 | ||
| EG001 | Level 6: 10.5 Gy/FX | SBRT 52.5 Gy SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy | 0 | 7 | 7 | 7 | ||
| EG002 | Level 7: 11.0 Gy/FX | SBRT 55.0 Gy SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy | 2 | 14 | 13 | 14 | ||
| EG003 | Level 8: 11.5 Gy/FX | 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 | 9 | 38 | 34 | 38 | ||
| EG004 | Level 9: 12.0 Gy/FX | 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 | 7 | 33 | 27 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophageal perforation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | 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 |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tricuspid valve disease | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophageal fistula | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophageal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophageal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal stenosis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophageal ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General 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 |
| |
| Bronchial infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tracheal hemorrhage | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Carbon monoxide diffusing capacity decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vital capacity abnormal | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Brachial plexopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myelitis | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Recurrent laryngeal nerve palsy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial fistula | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial stricture | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchospasm | 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 |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mediastinal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary fistula | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld, M.S. | NRG Oncology | seiferheldw@nrgoncology.org |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
|
|
| OG003 |
| Level 8: 11.5 Gy/FX |
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 |
| OG004 | Level 9: 12.0 Gy/FX | 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 |
|
|
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
| OG004 | Level 9: 12.0 Gy/FX | 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 |
|
|
| Level 7: 11.0 Gy/FX |
SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy |
| OG003 | Level 8: 11.5 Gy/FX | 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 |
| OG004 | Level 9: 12.0 Gy/FX | 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 |
|
|
| OG003 | Level 8: 11.5 Gy/FX | 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 |
| OG004 | Level 9: 12.0 Gy/FX | 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 |
|
|
| Level 8: 11.5 Gy/FX |
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 |
| OG004 | Level 9: 12.0 Gy/FX | 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 |
|
|
| OG004 | Level 9: 12.0 Gy/FX | 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 |
|
|
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 |
| OG004 | Level 9: 12.0 Gy/FX | 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 |
|
|