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

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.

Inclusion Criteria:

1. Histological confirmation of non-small cell cancer will be required by either biopsy
or cytology. The following primary cancer types are eligible: squamous cell carcinoma,
adenocarcinoma with or without BAC features, large cell carcinoma with or without
neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma,
or non-small cell carcinoma not otherwise specified.

2. Eligible patients must have appropriate staging studies identifying them as specific
subsets of the revised IASLC stage IA based on the following combination of TNM
staging: T1a,N0,M0 or T1b,N0,M0

3. A PET/CT scan is required. Patients with hilar or mediastinal lymph nodes with short
axis diameter considered N0. Patients with > 1 cm short axis diameter of hilar or mediastinal lymph
nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still
be eligible if directed tissue biopsy of all abnormally identified areas are negative
for cancer. Solitary pulmonary lesions
4. Patients must be considered a candidate for surgical resection of the primary tumor.
Standard justification for deeming a patient medically operable based on pulmonary
function for surgical resection of NSCLC may include any of the following: Baseline
FEV1 > 40% predicted, post-operative predicted FEV1 > 30% predicted, diffusion
capacity > 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise
oxygen consumption > 50% predicted, absent severe pulmonary hypertension, absent
severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic
heart disease.

5. Patients must be >/= 18 years of age.

6. The patient's Zubrod performance status must be Zubrod 0-2.

7. PET/CT scan to include both lungs, the mediastinum, and adrenal glands; Primary tumor
dimension will be measured on diagnostic CT and again on simulation CT. Must be done
within 10 weeks prior to study entry.

8. Mediastinoscopy or endobronchial ultrasound (EBUS) guided biopsy of mediastinal lymph
nodes is required for all patients. Must be done within 10 weeks of study entry.

9. MRI or CT scans of Brain if there are symptoms or signs suggesting brain metastases,
must be done within 10 weeks prior to study entry.

10. Invasive Mediastinal Staging - All patients with CT and/or PET evidence of hilar
(level 10) or mediastinal lymph nodes > 1.0 cm in the shortest diameter must be staged
by either cervical mediastinoscopy, esophageal endoscopic ultrasound guided biopsy, or
endobronchial ultrasound guided biopsy.

11. Patients must sign a study-specific consent form.

12. Patients (men and women) of child bearing potential should use an effective (for them)
method of birth control throughout their participation in this study.

Exclusion Criteria:

1. Patients with primary tumors > 3 cm.

2. Patients with well-differentiated neuroendocrine carcinoma (carcinoid tumor).

3. Direct evidence of regional or distant metastases after appropriate staging studies,
or synchronous primary or prior malignancy in the past 3 years other than
nonmelanomatous skin cancer or in situ cancer.

4. Previous lung or mediastinal radiotherapy.

5. Plans for the patient to receive other concomitant local therapy (including standard
fractionated radiotherapy and surgery) while on this protocol except at disease
progression.

6. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo
or fetus.

7. Cannot achieve acceptable SABR planning to meet minimal requirement of target coverage
and dose-volume constraints of critical structures (see RT techniques).