Stereotactic Body Radiation Therapy (SBRT) for Lung Tumors

NCT00632281 | Completed Results

• 1 other identifier: IRB # 502-2005
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Toxicity ot the Thorax

  up to 2 years, 9 months

Interventions

Stereotactic Body Radiation Therapy RADIATION

Prescription dose: 48 Gy or 60 Gy RT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Shands Cancer Center

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Bridget Fitzgerald, Clinical Research Coordinator
• Organization: University of Florida

fitzgb@shands.ufl.edu

352-265-0680

Study Officials

• Robert J Amdur, MD

  University of Florida- Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: January 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 20, 2012
• Results First Posted: February 20, 2012

Record last verified: 2010-06

Locations

US (1)