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Stereotactic Body Radiation Therapy for Tumors in the Thorax

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Lung Cancer

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Trial Information

Stereotactic Body Radiation Therapy for Tumors in the Thorax

Stereotactic Body Radiotherapy (SBRT) for tumors in the thorax is a relatively new therapy
in the United States, but has been used extensively in Japan for more than 10 years. This
protocol seeks to enroll patients in three broad categories based on histology and clinical
scenario: primary therapy for non-small-cell lung cancer (NSCLC), primary therapy to
thoracic metastases, and retreatment of previously irradiated tumors or lung.

Primary lung tumors

Several studies have been published describing the utility of Stereotactic Body Radiotherapy
(SBRT) for primary untreated lung tumors. In the United States, the most influential has
been the experience of Robert Timmerman at the University of Indiana (7). They enrolled 37
patients in a dose escalation trial of SBRT for T1 N0 and T2 N0 patients with Non-small-cell
lung cancer (NSCLC). The trial began with 24 Gy given in 3 fractions and escalated to 60 Gy
given in 3 fractions. Dose limited toxicity (DLT) was defined as any grade 3 pulmonary,
esophageal, cardiac, or pericardial toxicity, or any grade 4 toxicity that was ascribed to
the protocol treatment using the Common Toxicity Criteria from the National Cancer
Institute. The maximum tolerated dose (MTD) was defined at dose where less and 2 of 5
enrolled patients experienced DLT. The MTD was not determined by this trial as this
criteria was not met in the enrolled patients. Of the 37 patients, 2 experienced Grade 3
toxicity. One patient experienced pneumonitis and other patient experienced hypoxemia.
Both patients responded to therapy and made full recoveries. There were no long term
complications reported from the treatment at a mean follow-up of 15 months.

Inclusion Criteria:

- Informed consent to participate in this protocol

- Patients of all ages are eligible

- All tumor types are eligible

- Patients with prior thoracic radiotherapy and/or surgery are eligible

- Tumor size ≤ 5 cm

Exclusion Criteria:

- The subject is eligible for surgical resection or prefers treatment on this protocol
to surgical resection.

- Less than 1 year since original radiation to thorax for retreatment patients.

- More than 2 tumors requiring SBRT

- The patient cannot be positioned reproducibly due to pain or other factors

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Status

Outcome Description:

2-year local control (Percentage of tumors that did not recur at treated site 2 years after treatment), cause-specific survival (percentage of patients who had not died from disease under study in the 2 years since treatment), overall survival (percent of patients still alive at 2 years after treatment), and freedom from failure (percentage of patients in whom the disease treated had not progressed or recurred in the 2 years since treatment)

Outcome Time Frame:

2 yrs

Safety Issue:


Principal Investigator

Robert J Amdur, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida- Radiation Oncology


United States: Institutional Review Board

Study ID:

IRB # 502-2005



Start Date:

January 2006

Completion Date:

November 2008

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms



University of Florida Shands Cancer CenterGainesville, Florida  32610-0232