Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

Primary

• Compare time to local recurrence, in terms of recurrence within the same lobe or hilum (N1 nodes) or progression at the staple line (after treatment effects [i.e., scarring] have subsided), in high-risk patients with stage I non-small cell lung cancer treated with sublobar resection with vs without intraoperative brachytherapy.

Secondary

• Compare procedure-specific morbidity and mortality in patients treated with these regimens.

• Compare overall and failure-free survival of patients treated with these regimens.

• Compare freedom from regional or distant recurrence in patients treated with these regimens.

• Determine the effect of histologically or cytologically positive resection margins on time to local recurrence in patients treated with these regimens.

• Determine the effect of brachytherapy on quality of life of these patients.

• Determine the effect of brachytherapy on pulmonary function in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.

• Arm II: Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.

Quality of life is assessed at baseline and then at 3, 12, and 24 months.

After completion of study treatment, patients are followed at 3 and 6 months, every 6 months for 2.5 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 226 patients (113 per treatment arm) will be accrued for this study within 3 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• 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% of predicted

• DLCO ≤ 50% of predicted

• 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• See Disease Characteristics

Pulmonary

• See Disease Characteristics

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior intrathoracic radiotherapy

Surgery

• Not specified

Other

• Concurrent enrollment on ACOSOG-Z4031 (correlative science protocol) allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

American College of Surgeons

Hiran C. Fernando

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00107172
Information obtained from ClinicalTrials.gov on April 04, 2013

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