Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.

Key facts

Study ID

NCT00843726

Run by

Roswell Park Cancer Institute

People needed

98

Starts

2008-09-12

Expected to finish

2020-05-06

Last updated by the study team

2021-06-15

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed non-small cell lung cancer
• T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
• Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
• Age >= 18

You may not qualify if…

• Prior thoracic radiation therapy
• T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
• Node positive or metastatic disease
• Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
• No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
• Pregnant or unwilling to use adequate contraception

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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