Stereotactic Body Radiation Therapy (SBRT) for Lung Tumors

• ClinicalTrials.gov Identifier: NCT00632281
• Recruitment Status: Completed
• First Posted: March 10, 2008
• Results First Posted: February 20, 2012
• Last Update Posted: February 20, 2012
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

Brief Summary:

The purpose of this research study is to determine if Stereotactic Body Radiation Therapy(SBRT) 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 or disease	Intervention/treatment	Phase
Lung Cancer	Radiation: Stereotactic Body Radiation Therapy	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Stereotactic Body Radiation Therapy for Tumors in the Thorax
• Study Start Date: January 2006
• Actual Primary Completion Date: October 2008
• Actual Study Completion Date: November 2008

Arms and Interventions

Intervention Details:

• Radiation: Stereotactic Body Radiation Therapy
  Prescription dose: 48 Gy or 60 Gy RT

Outcome Measures

Primary Outcome Measures :

1. Disease Status [ Time Frame: 2 yrs ]
   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)

Secondary Outcome Measures :

1. Toxicity ot the Thorax [ Time Frame: up to 2 years, 9 months ]
   Toxicity is defined as adverse events described in the CTCAE (version 3). Acute toxicity refers to adverse events that occurred up until 3 months after treatment and "late" toxicity as those occurring 3 months or longer after the end of treatment. Below are the Rates of grade 2 acute toxicity, grade 3 acute toxicity, late grade 3 toxicity, and late grade 4 toxicity

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

Locations

United States, Florida

University of Florida Shands Cancer Center

Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: Robert J Amdur, MD; University of Florida- Radiation Oncology

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT00632281
• Other Study ID Numbers: IRB # 502-2005
• First Posted: March 10, 2008
• Results First Posted: February 20, 2012
• Last Update Posted: February 20, 2012
• Last Verified: June 2010