(RTOG 0813) Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located Non-Small Cell Lung Cancer (NSCLC) Medically Inoperable Patients

Title (RTOG 0813) Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located Non-Small Cell Lung Cancer (NSCLC) Medically Inoperable Patients
Contact DN
Principal Investigator Anurag Singh, MD
Study Number 153009
PhaseI/II
Summary

The usual treatment for early stage lung cancer is to remove the cancer with surgery. However, some patients may not be able to have standard surgery. Some patients cannot have surgery because of the location of their tumors. Some patients cannot have surgery because of other serious health problems like emphysema, diabetes, or heart disease.

Patients who cannot have surgery can receive radiation therapy. Standard therapy involves several weeks of daily treatment sessions. While this therapy is sometimes successful at killing the cancer, it is not as effective as surgery and may seriously damage normal surrounding lung tissue.

Stereotactic body radiation therapy (SBRT) is a newer radiation treatment that gives fewer but higher doses of radiation than standard radiation. It uses special equipment to position the patient and guide focused beams toward the cancer and away from normal surrounding tissue. The higher dose technique may work better to kill cancer cells potentially with fewer side effects than standard radiation therapy.

Eligibility
  • Pathologically proven diagnosis of non-small cell lung cancer (NSCLC)
  • Stage T1-T2, N0, M0, tumor size <= 5 cm prior to registration
  • History/physical exam within 4 weeks prior to registration
  • Evaluation by an experienced thoracic cancer surgeon within 12 weeks prior to registration
  • Imaging as follows: CT Scan with contrast within 8 weeks of registration; whole body positron emission tomography scan within 8 weeks of registration
  • Tumor within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the proximal bronchial tree. Tumors that are immediately adjacent to mediastinal or pericardial pleura (PTV touching the pleura) also are considered central tumors and are eligible for this protocol.
  • Patients must have measurable disease
  • Pleural effusion, if present, must be deemed too small to tap under CT guidance and must not be evident on chest x-ray.  Pleural effusion that appears on chest x-ray will be permitted only after thoracotomy or other invasive procedure(s).
For more information about the clinical study go to Clinicaltrial.Gov