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Stereotactic Body Radiation Therapy (SBRT) for Lung Tumors
This study is currently recruiting participants.
Verified by University of Florida, February 2008
First Received: February 29, 2008   Last Updated: March 7, 2008   History of Changes
Sponsored by: University of Florida
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00632281
  Purpose

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
Lung Cancer
Radiation: Stereotactic Body Radiation Therapy

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title: Stereotactic Body Radiation Therapy for Tumors in the Thorax

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Disease Status

Secondary Outcome Measures:
  • Toxicity

Estimated Enrollment: 750
Study Start Date: January 2006
Intervention Details:
    Radiation: Stereotactic Body Radiation Therapy
    Prescription dose: 48 Gy or 60 Gy RT
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632281

Contacts
Contact: Kenneth Olivier, MD 352-265-0287 kolivier@ufl.edu

Locations
United States, Florida
University of Florida Shands Cancer Center Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Kenneth Olivier, MD            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Kenneth Olivier, MD University of Florida- Radiation Oncology
  More Information

No publications provided

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

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on May 07, 2009