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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00107172
First received: April 5, 2005
Last updated: January 7, 2012
Last verified: January 2010
  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.


Condition Intervention Phase
Lung Cancer
Procedure: conventional surgery
Procedure: therapeutic thoracoscopy
Radiation: brachytherapy
Radiation: iodine I 125
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High Risk Patients With Non-Small Cell Lung Cancer (NSCLC), 3cm or Smaller

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to local recurrence [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Specific morbidity and mortality [ Designated as safety issue: No ]
  • Overall survival and failure-free survival [ Designated as safety issue: No ]
  • Freedom from regional or distant recurrence [ Designated as safety issue: No ]
  • Effect of histological or cytologic positive resection margins on time to local recurrence [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Pulmonary function [ Designated as safety issue: No ]

Estimated Enrollment: 226
Study Start Date: July 2005
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
Procedure: conventional surgery
No information available
Procedure: therapeutic thoracoscopy
No information available
Experimental: Arm II
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Procedure: conventional surgery
No information available
Procedure: therapeutic thoracoscopy
No information available
Radiation: brachytherapy
No information available
Radiation: iodine I 125
No information available

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107172

  Show 38 Study Locations
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Hiran C. Fernando, MD Boston Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: David M. Ota, American College of Surgeons Oncology Group
ClinicalTrials.gov Identifier: NCT00107172     History of Changes
Other Study ID Numbers: CDR0000422346, ACOSOG-Z4032
Study First Received: April 5, 2005
Last Updated: January 7, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014