Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Carcinoma, Neuroendocrine

Carcinoma, Large Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

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.

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.

Stereotactic Body Radiotherapy (SABR)

Jack Roth, MD, BA

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.

Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy

STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy

OS defined as the length of time measured from the start of treatment until 3 years post-treatment or death, whichever come first.

Varian Medical Systems

M.D. Anderson Cancer Center

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.

Surgery (S) vs. SBRT

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy	NCT02357992	Lung Cancer	Stereotactic Bo...	18 Years -	M.D. Anderson Cancer Center
Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy	NCT02357992	Lung Cancer	Stereotactic Bo...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for stereotactic body radiotherapy (sabr)