A Phase I/II Trial of Stereotactic Body Radiation Therapy

ELIGIBILITY:

Inclusion Criteria

* Histologically confirmed non-small cell cancer by biopsy or cytology. Squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar carcinoma, or non-small cell carcinoma (not otherwise specified) are allowed.
* Staging studies must identify patient as AJCC Stage I or II based on only 1 of following combinations of TNM staging:

  * T1, N0, M0
  * T2 (\<=7cm), N0, M0
  * T3 (\<=7cm), N0, M0
* Primary tumor must be arising in one of the following central chest locations:

  * Within or touching the zone of the proximal bronchial tree (a volume 2cm in all directions around the proximal bronchial tree \[carina, R \& L main bronchi, R \& L upper lobe bronchi, intermedius bronchus, R middle lobe bronchus, lingular bronchus, R \& L lower lobe bronchi\])
  * Adjacent to (within 5 mm) or invading the mediastinal pleura
  * Adjacent to (within 5 mm) or invading the parietal pericardium
* To differentiate T3 lesions involving the mediastinal pleura from T4 lesions involving major vessels or organs, a chest MRI will be obtained. If any uncertainty remains, the patient will have four-dimensional CT scans (4DCT) in an effort to determine the degree of tumor motion. A freely mobile tumor during ventilation will be judged to be T3 disease.
* Patients with hilar or mediastinal lymph nodes \<=1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with \>1cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer.
* Primary tumor must be technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (potentially curative resection, PCR). However, patients must have underlying physiological medical problems prohibiting PCR (i.e., problems with general anesthesia, the operation, the post-op recovery period, or removal of adjacent functioning lung) or refuse surgery. Deeming a patient medically inoperable based on pulmonary function for surgical resection may include any of the following: baseline FEV1 \<40% predicted; post-operative predicted FEV1 \<30% predicted; severely reduced diffusion capacity; baseline hypoxemia and/or hypercapnia; exercise oxygen consumption \<50% predicted; severe pulmonary hypertension; diabetes with severe end organ damage; severe cerebral, cardiac, or peripheral vascular disease; or severe chronic heart disease. Any one of these problems will qualify a patient for this trial.
* Age \>=18.
* Zubrod performance status 0-2.
* Women of childbearing potential must use effective contraception.
* No direct evidence of regional or distant metastases after appropriate staging studies. No synchronous primary or prior malignancy in past 2 years except non-melanoma skin cancer or in situ cancer.
* No previous lung or mediastinal radiation therapy.
* No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemo, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.
* No active systemic, pulmonary, or pericardial infection.
* No pregnant or lactating women.
* PRESTUDY REQUIREMENTS:

  * History and Physical Examination, Weight, Zubrod performance status (within 4 weeks pre-study entry)
  * Evaluation by thoracic cancer clinician (within 8 weeks pre-study entry)
  * Pregnancy test, if applicable (serum or urine, within 72 hours prior to treatment start.)
  * CT (preferably with contrast unless medically contraindicated; both lungs, mediastinum, liver, adrenals)
  * PET (using FDG with visualization of primary tumor and draining lymph node basins in hilar and mediastinal regions)
  * Brain MRI or head CT with contrast
  * PFTs - include routine spirometry, lung volumes, diffusion capacity
  * Signed informed consent.

Exclusion Criteria:

There is no exclusion criteria associated with this protocol. Please see the above inclusion criteria.-