Status:
TERMINATED
Proton Stereotactic Body Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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...
Detailed Description
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 mo...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed non-small cell lung cancer (need not be newly diagnosed)
- Stage clinical T1 N0 M0 or T2 N0 M0
- NSCLC must be limited to a single lesion
- NSCLC must be peripherally located (\> 2 cm from proximal bronchial tree and \> 1 cm from mediastinal pleura)
- NSCLC must be considered medically inoperable
- Life expectancy greater than 6 months
Exclusion
- Pregnant or breastfeeding
- Prior radiation therapy to the lungs or mediastinum
- Prior malignancy in the last 2 years unless treated definitively and disease free or carcinoma in situ or early stage skin cancers that have been definitively treated
- Receiving other study agents or other types of cancer therapy
- Uncontrolled intercurrent illness
- Pacemaker or defibrillator-dependent
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01525446
Start Date
September 1 2011
End Date
December 1 2015
Last Update
February 17 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214