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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00632281 |
The purpose of this research study is to determine if Stereotactic Body Radiation Therapy is a good way to treat tumors near the thorax. Stereotactic Body Radiation Therapy (SBRT) is a general term for a group of techniques that are designed to deliver radiation therapy in a way that damages normal tissues less than conventional radiotherapy. The two features that distinguish SBRT from conventional therapy are procedures that decrease errors in patient positioning and technology that results in a radiation dose distribution that conforms more tightly to the tumor target. Patients will receive either 48 Gy or 60 Gy fractions depending on the type of tumor. The majority of patients will be treated in 1 week, Monday through Friday, with
Wednesday off.
Condition | Intervention |
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Lung Cancer |
Radiation: Stereotactic Body Radiation Therapy |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Stereotactic Body Radiation Therapy for Tumors in the Thorax |
Estimated Enrollment: | 750 |
Study Start Date: | January 2006 |
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 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 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 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kenneth Olivier, MD | 352-265-0287 | kolivier@ufl.edu |
United States, Florida | |
University of Florida Shands Cancer Center | Recruiting |
Gainesville, Florida, United States, 32610 | |
Principal Investigator: Kenneth Olivier, MD |
Principal Investigator: | Kenneth Olivier, MD | University of Florida- Radiation Oncology |
Study ID Numbers: | IRB # 502-2005 |
Study First Received: | February 29, 2008 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00632281 History of Changes |
Health Authority: | United States: Institutional Review Board |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases |