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Therapeutic Areas: Oncology | Pulmonary/Respiratory Diseases | Family Medicine
Disease Category: Non-Small Cell Lung Cancer
Location: United States, NJ

Clinical Trial Details

Overview

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

Purpose

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:
    • 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
Gender

Both Male and Female

Age

75 and up

Overall Status

Recruiting

Facility Type

N/A

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
Phone: 201-634-5792

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Research Center Information: The Valley Hospital/Valley Health System

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 122105

Date Last Changed: July 25, 2013


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