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

Lung Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT02357992
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: N/A
• Start date: April 5, 2010
• Completion date: September 17, 2021