Status:
COMPLETED
Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more e...
Detailed Description
OBJECTIVES: Primary * To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell...
Eligibility Criteria
Inclusion
- Histologically confirmed non-small cell lung cancer
- T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded)
- Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection
- Age \>= 18
Exclusion
- Prior thoracic radiation therapy
- T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement
- Node positive or metastatic disease
- Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree.
- No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly)
- Pregnant or unwilling to use adequate contraception
Key Trial Info
Start Date :
September 12 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2020
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00843726
Start Date
September 12 2008
End Date
May 6 2020
Last Update
June 15 2021
Active Locations (3)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
2
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195