Proton Stereotactic Body Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer
Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints high doses of radiation directly to cancer. Standard radiation (or photon radiation) is commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is a special type of radiation only available at a few institutions in the US and has not been previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue.
In this study, the investigators are evaluating the safety and effectiveness of proton-based SBRT for early-stage NSCLC located in the periphery of the lung.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Proton Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable, Peripheral Early-Stage Non-Small Cell Lung Cancer (NSCLC): A Pilot Study|
- Feasibility and safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To establish the feasibility and safety of fiducials placement by electromagnetic navigational brochoscopy (ENB)
- Safety and tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Frequency of radiation pneumonitis in participants treated with proton radiation
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Describe the acute and late toxicities of treatment using CTCAE v4.0
- Efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]To describe radiological tumor responses
- Disease Free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]To calculate local, regional, and distant failure rates
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]To calculate the overall survival rate
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Radiation: SBRT with proton beam radiation
Subjects will undergo an electronic navigational bronchoscopy (ENB) during which three markers will be placed around their tumor which will guide the delivery of proton beam radiation to their with more precision and accuracy.
Subjects will receive a CT scan to obtain images to plan radiation treatment. Proton radiation will be delivered daily (4 or 5 consecutive days) on an outpatient basis at Massachusetts General Hospital.
After the final dose of proton radiation subjects will be followed for 5 years. Subjects will be asked to return at 6 weeks, 3 months, and then every 3 months until 2 years, and then every 6 months until 5 years. Subjects will receive a chest CT, tumor assessment by CT or PET, chest x-ray, pulmonary function tests and a physical exam.
|Contact: Henning Willers, M.D.||firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02214|
|Principal Investigator: Henning Willers, M.D.|
|Principal Investigator:||Henning Willers, M.D.||Massachusetts General Hospital|