Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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|
- Time to Local Recurrence [ Time Frame: Up to 3 years ]Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.
- Overall Survival (OS) [ Time Frame: Up to 5 years ]OS was defined as the time from randomization to death due to any cause.
- Number of Participants Reported Local Recurrence at 3 Years [ Time Frame: 3 years ]Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.
- Number of Participants Reported Regional Recurrence at 3 Years [ Time Frame: 3 years ]Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.
- Number of Participants Reported Distant Recurrence at 3 Years [ Time Frame: 3 years ]
Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant
> metastatic disease (other organs).
- Mortality Rates at 30- and 90-day After Sublobar Resection [ Time Frame: 90 days ]
- Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection [ Time Frame: 90 days ]Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
- Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection [ Time Frame: 90 days ]The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.
- Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24 [ Time Frame: 24 months ]Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores <50 indicate below-average health status.
- Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24 [ Time Frame: 24 months ]Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..
- FEV1% Measured at Baseline and Month 3 [ Time Frame: 3 months ]Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms
- DLCO% Measured at Baseline and Month 3 [ Time Frame: 3 months ]
Pulmonary function tests included percentage predicted carbon
> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms.
|Study Start Date:||July 2005|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
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: surgery Radiation: brachytherapy|
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107172
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|Study Chair:||Hiran C. Fernando, MD||Boston Medical Center|