Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung
Non Small Cell Lung Cancer
Radiation: Stereotactic Body Radiation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||INST 0810: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung|
- Response Rate (RR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]RR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. RR is the sum of the percentage of patients who achieved a CR or PR. (RR = CR + PR)
- Toxicity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated and reported.
- Overall Survival (OS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]The time from treatment initiation to death by any cause
- Progression free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Clinical Benefit Rate (CBR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]CBR is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. CBR is the sum of the percentage of patients who achieve a CR, PR or SD (CBR = CR + PR + SD).
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Stereotactic Body Radiation (SBRT)
60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days
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%.
Other Name: SBRT
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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832780
|United States, New Mexico|
|Universtiy of New Mexico Comprehensive Cancer Center|
|Albuquerque, New Mexico, United States, 87131-0001|
|Principal Investigator:||Ben Liem, M.D||University of New Mexico Comprehensive Cancer Center|