Stereotactic Body Radiation Therapy (SBRT) for Lung Tumors

Lung Cancer Clinical Trial

Official title:

Stereotactic Body Radiation Therapy for Tumors in the Thorax

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632281
• Other study ID #: IRB # 502-2005
• Status: Completed
• Phase: N/A
• First received: February 29, 2008
• Last updated: January 17, 2012
• Start date: January 2006
• Est. completion date: November 2008

Study information

• Verified date: June 2010
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida Shands Cancer Center	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Status	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)	2 yrs	No
Secondary	Toxicity ot the Thorax	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	up to 2 years, 9 months	No