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Trial Information
Summary: Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High-Risk Patients with Non-Small Cell Lung Cancer (NSCLC), 3cm or Smaller
Rationale:
Surgery may be an effective treatment for non-small cell lung
cancer. Internal radiation uses radioactive material placed
directly into or near a tumor to kill tumor cells. It is not yet
known whether surgery and internal radiation therapy are more
effective than surgery alone in treating non-small cell lung
cancer.
Purpose:
This randomized phase III trial is studying surgery and internal
radiation therapy to see how well they work compared to surgery
alone in treating patients with stage I non-small cell lung
cancer.
Patient Inclusion Criteria:
Suspected or proven non-small
cell lung cancer (NSCLC), meeting both of the following
criteria:
- Pre-operative criteria:
- Lung nodule suspicious for clinical stage I NSCLC
- Mass = 3 cm in maximum diameter by CT scan of the chest and
upper abdomen
- Clinical stage IA OR selected stage IB with visceral pleural
involvement
- Intra-operative criteria:
- Histologically proven stage I NSCLC
- All suspicious mediastinal lymph nodes (> 1 cm short-axis
dimension on CT scan OR positive on positron-emission tomography
scan) must be negative by mediastinoscopy, endoscopic
ultrasound-guided needle aspiration, or CT-guided, video-assisted
thoracoscopic, or open lymph node biopsy
Meets = 1 major OR = 2 minor high-risk criteria, defined as
the following:
- Major criteria:
- Minor criteria:
- Age 75 and over
- FEV_1 51-60% of predicted
- DLCO 51-60% of predicted
- Pulmonary hypertension, defined as pulmonary artery systolic
pressure > 40 mm Hg by echocardiography or right heart
catheterization
- LVEF = 40%
- Resting or exercise arterial oxygen partial pressure = 55 mm Hg
or oxygen saturation = 88% by pulse oximetry
- Arterial carbon dioxide partial pressure > 45 mm Hg
- Modified Medical Research Council Dyspnea Scale =
3
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Contact:
Cheryl Parish, RN, Manager, Oncology Clinical Trials
The Valley Hospital/Valley Health System
The Daniel and Gloria Blumenthal Cancer Center
One Valley Health Plaza
Paramus, NJ 07652
Telephone: 201-634-5792
Email:
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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Trial listings updated: June 1, 2008 at 6:34:03 AM
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