Status:
TERMINATED
Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotact...
Detailed Description
OBJECTIVES: * To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer. * To e...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer
- Stage I or II disease (T1-3, N0, M0)
- T2 or T3 tumor ≤ 5 cm
- No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
- Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"
- Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
Exclusion
- No history of contrast allergy
- No psychological issues that would preclude the completion of study treatment
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 \[FDG\]-avid or measure \> 1 cm in short axis diameter on CT scan)
- No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00852644
Start Date
January 1 2009
End Date
August 1 2016
Last Update
May 11 2018
Active Locations (1)
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1
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118