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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00107172
First received: April 5, 2005
Last updated: July 23, 2015
Last verified: July 2015

April 5, 2005
July 23, 2015
July 2005
April 2011   (final data collection date for primary outcome measure)
Time to local recurrence [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00107172 on ClinicalTrials.gov Archive Site
  • Specific morbidity (any grade 3 or higher adverse events or hospitalization) and mortality (death or in-hospital death) [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to 5 years ] [ 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

This randomized phase III trial studies 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. 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.

PRIMARY OBJECTIVES:

I. To ascertain whether patients treated by sublobar resection (SR) + brachytherhapy (BX) have longer time to local recurrence as compared to the patients treated by SR (local recurrence includes recurrence within the same lobe or hilum [N1 nodes], or progression at the staple line after treatment effects such as scarring have subsided).

SECONDARY OBJECTIVES:

I. To compare procedure specific morbidity and mortality between study arms. II. To compare overall survival and failure-free survival between study arms. III. To assess freedom from regional or distant recurrence. IV. To assess the effect of histological or cytologic positive resection margins on time to local recurrence.

V. To determine the effect of brachytherapy on quality of life (QoL). VI. To determine the effect of brachytherapy on pulmonary function.

OUTLINE: 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 iodine I 125 implant at the resection margin.

After completion of study treatment, patients are followed at 3, 6, 12, 18, 24, 30, and 36 months and then yearly for 2 years.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION)
  • Patients must have a suspicious lung nodule for clinical stage I non-small cell lung cancer (NSCLC)
  • Patient must have a mass =< 3 cm maximum diameter by computed tomography (CT) size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)
  • Patient must have a CT scan of the chest with upper abdomen within 60 days prior to date of pre-registration
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2
  • Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below:

    • Major criteria

      • Forced expiratory volume in 1 second (FEV1) =< 50% predicted
      • Diffusing capacity of the lungs for carbon monoxide (DLCO) =< 50% predicted
    • Minor criteria

      • Age >= 75
      • FEV1 51-60% predicted
      • DLCO 51-60% predicted
      • Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
      • Poor left ventricular function (defined as an ejection fraction of 40% or less)
      • Resting or exercise partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88%
      • Partial pressure of carbon dioxide (pCO2) > 45 mm Hg
      • Modified Medical Research Council (MMRC) Dyspnea Scale >= 3
  • Patient must not have had previous intra-thoracic radiation therapy
  • Women of child-bearing potential must have negative serum or urine pregnancy test
  • No prior invasive malignancy, unless disease-free for >= 5 years prior to pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers)
  • PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION)
  • Patient must have biopsy-proven NSCLC
  • Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on positron emission tomography [PET] scan) assessed by one of the following methods to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00107172
ACOSOG-Z4032, ACOSOG-Z4032, CDR0000422346
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Hiran C. Fernando, MD Boston Medical Center
Alliance for Clinical Trials in Oncology
July 2015

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