Clinical Trial Details


Research Study Summary

Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High-Risk Patients with Non-Small Cell Lung Cancer (NSCLC), 3cm or Smaller


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.

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:
    • FEV_1 = 50%
    • DLCO = 50%
  • 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
To Learn more

CW ID: 122105
Date Last Changed: July 25, 2013

Clinical Trial Snapshot

Both Male and Female
75 and up
Overall Status
Facility Type


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
Phone: 201-634-5792

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Research Center Information:

The Valley Hospital/Valley Health System

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