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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00536 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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The goal of this clinical research study is to evaluate the outcome of a standard radiation treatment called stereotactic radiotherapy (SRT) for NSCLC.
Specifically, researchers want to learn if standard SRT has as good of an outcome at 3 years after the procedure. The safety of the study treatment will also be analyzed.
The Study Treatment:
The treatment being used in this study is considered standard, but researchers want to see its outcome in early-stage NSCLC.
The radiation (SRT) in this study is designed to kill tumor cells by using beams of radiation aimed directly at the tumor from different angles. The doctor uses computed tomography (CT) scans to plan exactly where to direct the beams to go. A computer is used to show the location, size, and shape of the tumor. SRT is designed to cause less damage to normal tissue than surgery, and it also may allow a higher dose of radiation to be given to the tumor than if other forms of radiation therapy were used.
The SRT in this study will be performed using a radiation machine called Linear Accelerator (Linac).
Study Group:
If you are found to be eligible to take part in this study, you will receive SRT (as an out-patient) once a day for 3-4 days in a row. You will be asked to hold still during the entire treatment (for about 1 to 1 1/2 hours each time). The machine will move around you, but you will not see or feel anything (similar to getting an x-ray).
Follow-Up Visits:
During the treatment period, you will be seen by a doctor and/or research nurse in order to check for any side effects. A physical exam will be performed, and your medical history will be recorded. These follow-up procedures will be done once on any day of your SRT.
A physical exam will be performed and your medical history will be recorded at 6 and 12 months, then at 1 1/2, 2, 3, 4, and 5 years after your SRT. If the doctor decides it is necessary, you will have a chest x-ray to check the status of the disease.
At 6 to 12 months after SRT, you will have either a PET-CT scan or CT scan to check the status of the disease.
At 1 year after SRT, you will have breathing tests to check your lung function. You will also have a CT scan to check the status of your disease.
At 1 1/2 year and then at 2, 3, 4, and 5 years after SRT, you will have a CT scan to check the status of your disease.
Possible Re-Treatment On Study:
If one of your follow-up CT scans shows that the tumor has come back in the same location or very close, you will have a PET scan and a tumor biopsy. The purpose is to confirm the status of the disease. To collect a tumor biopsy, the affected area is numbed with anesthetic, and a small amount of tissue is withdrawn through a large needle.
As soon as the results of the scan and biopsy come back, the study doctor will discuss with you the different treatment options. You may receive surgery, radiation therapy, or chemotherapy, depending on the status of the disease. You will receive a separate consent form that describes the treatment in more detail, as well as the risks.
After this "re-treatment", you will stay on the same schedule for study follow-up visits as you were following before.
Length of Study Participation:
Your participation in this study will be over after the 5-year follow-up visit.
This is an investigational study. The treatment is commercially available and considered standard for early-stage NSCLC. This includes the use of the Linac radiation machine, which is FDA approved and commercially available.
Up to 80 treated patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiotherapy (SRT) | Experimental | Participants receive stereotactic body radiotherapy (SABR) once a day for 3-4 days in a row. 50Gy delivered in 4 fractions for central tumor, or 54Gy delivered in 3 fractions for peripheral tumor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiotherapy (SABR) | Radiation | SABR once a day for 3-4 days in a row, 50Gy in 4 fractions for central tumor, or 54Gy in 3 fractions for peripheral tumor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Survival (OS) at 3 Years | OS defined as the length of time measured from the start of treatment until 3 years post-treatment or death, whichever come first. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jack Roth, MD, BA | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34529930 | Derived | Chang JY, Mehran RJ, Feng L, Verma V, Liao Z, Welsh JW, Lin SH, O'Reilly MS, Jeter MD, Balter PA, McRae SE, Berry D, Heymach JV, Roth JA; STARS Lung Cancer Trials Group. Stereotactic ablative radiotherapy for operable stage I non-small-cell lung cancer (revised STARS): long-term results of a single-arm, prospective trial with prespecified comparison to surgery. Lancet Oncol. 2021 Oct;22(10):1448-1457. doi: 10.1016/S1470-2045(21)00401-0. Epub 2021 Sep 13. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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A total of 122 participants were consented; 6 were screen failures.
Recruitment Period: April 2010- January 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery (S) vs. SBRT | These patients were randomized to surgery vs. SBRT. Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings. The type of resection chosen should provide complete removal of the primary lesion with negative gross and microscopic margins. Documentation of margins (bronchial and vascular and any other required) by frozen sections at surgery is recommended. Limited resection including wedge or segmental resections should not be performed unless there are unforeseen problems at the time of surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 28, 2020 |
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|
| FG001 | Stereotactic Body Radiation Therapy (SBRT) (R) | SBRT for lung cancer utilizes elements of 3-DCRT and also incorporates a variety of systems for taking cancer motion into consideration and decreasing set-up uncertainty using image guided radiotherapy techniques (9). These systems allow reduction of treatment volumes facilitating hypofractionation with markedly increased daily doses (>10 GY) and a significantly reduced overall treatment time. The combination of multiple beam angles to achieve sharp dose gradients, high precision localization and a high dose per fraction in extracranial locations are referred to as SBRT. This approach delivers a high biological effective dose (BED) to the target while minimizing the normal tissue toxicities, this may translate into improved local control and survival. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgery (S) vs. SBRT | These patients were randomized to surgery vs. SBRT. Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings. The type of resection chosen should provide complete removal of the primary lesion with negative gross and microscopic margins. Documentation of margins (bronchial and vascular and any other required) by frozen sections at surgery is recommended. Limited resection including wedge or segmental resections should not be performed unless there are unforeseen problems at the time of surgery. |
| BG001 | Stereotactic Body Radiation Therapy (SBRT) (R) | SBRT for lung cancer utilizes elements of 3-DCRT and also incorporates a variety of systems for taking cancer motion into consideration and decreasing set-up uncertainty using image guided radiotherapy techniques (9). These systems allow reduction of treatment volumes facilitating hypofractionation with markedly increased daily doses (>10 GY) and a significantly reduced overall treatment time. The combination of multiple beam angles to achieve sharp dose gradients, high precision localization and a high dose per fraction in extracranial locations are referred to as SBRT. This approach delivers a high biological effective dose (BED) to the target while minimizing the normal tissue toxicities, this may translate into improved local control and survival. |
| BG002 | 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, Categorical | 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 |
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| 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 | Number of Participants With Overall Survival (OS) at 3 Years | OS defined as the length of time measured from the start of treatment until 3 years post-treatment or death, whichever come first. | Posted | Count of Participants | Participants | 3 years |
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Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
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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 (S) vs. SBRT | These patients were randomized to surgery vs. SBRT. Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings. The type of resection chosen should provide complete removal of the primary lesion with negative gross and microscopic margins. Documentation of margins (bronchial and vascular and any other required) by frozen sections at surgery is recommended. Limited resection including wedge or segmental resections should not be performed unless there are unforeseen problems at the time of surgery. | 5 | 36 | 3 | 36 | 3 | 36 |
| EG001 | Stereotactic Body Radiation Therapy (SBRT) (R) | SBRT for lung cancer utilizes elements of 3-DCRT and also incorporates a variety of systems for taking cancer motion into consideration and decreasing set-up uncertainty using image guided radiotherapy techniques (9). These systems allow reduction of treatment volumes facilitating hypofractionation with markedly increased daily doses (>10 GY) and a significantly reduced overall treatment time. The combination of multiple beam angles to achieve sharp dose gradients, high precision localization and a high dose per fraction in extracranial locations are referred to as SBRT. This approach delivers a high biological effective dose (BED) to the target while minimizing the normal tissue toxicities, this may translate into improved local control and survival. | 10 | 80 | 8 | 80 | 3 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection-lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Death, NOS (unknown) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection-Other (sepsis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection-Other (COPD/pulmonary) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lung fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rib fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jack Roth, MD- Professor, Thoracic & Cardio Surgery-Rsch | UT MD Anderson Cancer Center | (713) 792-7664 | jroth@mdanderson.org |
| Apr 5, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002294 | Carcinoma, Squamous Cell |
| D018278 | Carcinoma, Neuroendocrine |
| 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 |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D000230 | Adenocarcinoma |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|