Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I non-small cell lung cancer.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margaret Hospital, Toronto, Ontario, Canada

About this study

OBJECTIVES:

Primary

To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in medically inoperable patients with centrally located stage I non-small cell lung cancer. (Phase I)
To estimate the local control rate of SBRT at the MTD in these patients. (Phase II)

Secondary

To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade 3 that is possibly, probably, or definitely related to treatment and that occurs within 1 year after the start of SBRT in these patients.
To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of SBRT) in these patients.
To estimate the local control and progression-free and overall survival rates in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks [total of 5 fractions (FX)] in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 2 years, then annually.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

Stage T1-2, N0, M0 disease

Tumor size ≤ 5 cm
Tumor must be within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (i.e., carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right, and left lower lobe bronchi) OR immediately adjacent to the mediastinal or pericardial pleura (PTV touching the pleura)
Hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on positron emission tomography (PET) scan are considered N0

Mediastinal lymph node sampling by any technique is allowed but not required
Patients with > 1 cm hilar or mediastinal lymph nodes on CT scan or abnormal PET scan (including suspicious but nondiagnostic uptake) are eligible provided directed tissue biopsies of all abnormally identified areas are negative for cancer
Tumor deemed technically resectable, in the opinion of an experienced thoracic cancer surgeon, with a reasonable possibility of obtaining a gross total resection with negative margins, defined as a potentially curative resection (PCR)
Patient deemed "medically inoperable" due to severe underlying physiological medical problems that would prohibit a PCR, including any of the following:

Baseline forced expiratory volume at one second (FEV1) < 40% predicted
Postoperative FEV1 < 30% predicted
Severely reduced diffusion capacity
Baseline hypoxemia and/or hypercapnia
Exercise oxygen consumption < 50% predicted
Severe pulmonary hypertension
Diabetes mellitus with severe end-stage organ damage
Severe cerebral, cardiac, or peripheral vascular disease
Severe chronic heart disease
Measurable disease as documented by CT scan or whole-body PET scan within the past 8 weeks

Patients with lesions that cannot be visualized by CT scan are not eligible
Pleural effusion allowed provided it is deemed too small to tap under CT guidance and is not evident on chest x-ray

Pleural effusion that appears on chest x-ray is allowed only after thoracotomy or other invasive procedure

PATIENT CHARACTERISTICS:

Zubrod performance status 0-2
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 60 days after completion of study therapy
No other invasive malignancy within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix

Prior lung cancer allowed provided the patient has been disease-free for ≥ 2 years

PRIOR CONCURRENT THERAPY:

No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
No prior chemotherapy for the study cancer
No other concurrent local therapy (including standard-fractionated radiotherapy and/or surgery) or systemic therapy (including standard chemotherapy or biologic targeted agents) specifically intended as treatment for study cancer

Local or systemic therapy at the time of disease progression allowed