Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments conventional surgery, therapeutic thoracoscopy, brachytherapy, iodine i 125
Phase phase 3
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date July 2005
End date April 2011
Trial size 226 participants
Trial identifier NCT00107172, ACOSOG-Z4032, CDR0000422346

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
conventional surgery
No information available
therapeutic thoracoscopy
No information available
(Experimental)
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
conventional surgery
No information available
therapeutic thoracoscopy
No information available
brachytherapy
No information available
iodine i 125
No information available

Primary Outcomes

Measure
Time to local recurrence
time frame: Up to 3 years

Secondary Outcomes

Measure
Specific morbidity (any grade 3 or higher adverse events or hospitalization) and mortality (death or in-hospital death)
time frame: Within 30 days
Overall survival (OS)
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.