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Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive care, TreatmentClosed18 and overNCI, OtherCDR0000422346
ACOSOG-Z4032, SRCI, NCT00107172

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

National Cancer Institute

Hiran C. FernandoStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00107172
ClinicalTrials.gov processed this data on March 16, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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