NCT00832780

Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

INST 0810: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the response of lung tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety.

Detailed description

The introduction of stereotactic body radiation therapy (SBRT) has allowed safe dose escalation in treatment regimens for cancer. Several studies have shown a radiation dose-response relationship for survival and local control for tumors of the lung, including cancer that originates in the lung (such as non-small cell lung cancer) as well as cancer that metastasizes to the lung. The purpose of this study is to determine the response rate and toxicity of SBRT treatment of patients with lung tumors. This study will use a dose of 60 gray (Gy) in 5 fractions of 12 Gy. This provides a biological equivalent dose with alpha/beta ratio of 10 (BED10) of 132 Gy with the anticipation of achieving local control without increased toxicity. Previous studies have shown that the response rate with SBRT across multiple studies is approximately 50%, with an additional 25-40% of patients having stable disease. We hypothesize that this regimen will achieve a response rate of 70% with grade 3 toxicity of less than 5%.

Conditions

• Lung Cancer
• Non Small Cell Lung Cancer
• Solid Tumors

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation	A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%.

Timeline

• Start date: 2008-01-01
• Primary completion: 2015-12-01
• Completion: 2018-12-01
• First posted: 2009-01-30
• Last updated: 2021-05-21
• Results posted: 2018-05-11

Locations

1 site across 1 country: United States