Stereotactic Body Radiation Therapy in Stage II/III Non Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT01657617|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2012
Last Update Posted : March 15, 2017
It is apparent that local control for Non-small Cell Lung Cancer (NSCLC) remains a significant problem. Conventional radiation therapy techniques have limitations for the dose that can be delivered to a chest tumor mass due to the adjacent dose limiting organs. Mounting evidence supports the use of hypofractionated stereotactically delivered radiation therapy to control lung cancer with acceptable toxicity profiles.
Thus the investigators propose to increase the doses of radiation to residual masses of NSCL to a BED > 100 Gy by the addition of two fractions of stereotactically delivered boost radiation therapy to residual disease post-conventional chemoradiation to at least 59.4 Gy in 180 cGy fractions. Using the linear quadratic equation to model doses of radiation therapy, 59.4 Gy would have a BED of approximately 70 Gy. Single fraction stereotactic body radiation therapy (SBRT) of 10 Gy would have a BED of approximately 20 Gy. Thus the addition of two fractions of 10Gy of SBRT to limited volumes of PET residual disease would theoretically result in higher degrees of local control of lung cancer masses, achieving a minimum cumulative BED of approximately 110Gy-equivalent.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: Boost Stereotactic Body Radiation Therapy||Phase 2|
Lung cancer represents one of the most challenging malignancies to manage. Cure rates have only marginally improved in the last 20 years. It is the most commonly fatal cancer in both men and women with overall 5 year survivals of 15%. Lung cancer kills more Americans than the next three most common malignancies combined.
Most non small cell lung cancer (NSCLC) presents at advanced stages. Only approximately 25% present with stage I/II disease, 40% with stage III and 35% patients present with stage IV. (1) The optimal treatment of stage II/III NSCLC is complex. For those patients who are surgical candidates and a complete resection is technically feasible, radical surgery remains the standard of care. Traditionally, those patients with multiple N2 nodal levels or T4 disease are considered inoperable. Given that the average age of patients diagnosed with NSCLC is in their mid-60's and usually have long smoking histories, many patients are medically inoperable.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Body Radiation Therapy for Post-chemoradiation Residual Disease in Stage II/III Non-small Cell Lung Cancer|
|Study Start Date :||October 2007|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Radiation Therapy
Boost Stereotactic Body Radiation Therapy
Radiation: Boost Stereotactic Body Radiation Therapy
The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:
Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.
Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy.
- To determine the toxicity of the SBRT boost dose by estimating the proportion of subjects enrolled who develop pneumonitis [ Time Frame: 30 days post SBRT ]
- To determine response rates of the residual primary tumor following SBRT boost using a modified version of the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [ Time Frame: 30 days post SBRT ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657617
|United States, Kentucky|
|Markey Cancer Center|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Ronald C. McGarry, MD, PhD.||University of Kentucky|