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

April 5, 2005
January 7, 2012
July 2005
August 2012   (final data collection date for primary outcome measure)
Time to local recurrence [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00107172 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Lung Cancer
  • Procedure: conventional surgery
    No information available
  • Procedure: therapeutic thoracoscopy
    No information available
  • Radiation: brachytherapy
    No information available
  • Radiation: iodine I 125
    No information available
  • Active Comparator: Arm I
    Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
    Interventions:
    • Procedure: conventional surgery
    • Procedure: therapeutic thoracoscopy
  • 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.
    Interventions:
    • Procedure: conventional surgery
    • Procedure: therapeutic thoracoscopy
    • Radiation: brachytherapy
    • Radiation: iodine I 125

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
226
Not Provided
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00107172
CDR0000422346, ACOSOG-Z4032
Not Provided
David M. Ota, American College of Surgeons Oncology Group
American College of Surgeons
National Cancer Institute (NCI)
Study Chair: Hiran C. Fernando, MD Boston Medical Center
National Cancer Institute (NCI)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP