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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 224
- Locations
- 38
- Primary Endpoint
- Time to Local Recurrence
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
Intervention: surgery (Procedure)
Arm II
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Intervention: surgery (Procedure)
Arm II
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Intervention: brachytherapy (Radiation)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Mortality Rates at 30- and 90-day After Sublobar Resection(90 days)
- Overall Survival (OS)(Up to 5 years)
- Number of Participants Reported Local Recurrence at 3 Years(3 years)
- Number of Participants Reported Regional Recurrence at 3 Years(3 years)
- Number of Participants Reported Distant Recurrence at 3 Years(3 years)
- Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection(90 days)
- Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection(90 days)
- Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24(24 months)
- Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24(24 months)
- FEV1% Measured at Baseline and Month 3(3 months)
- DLCO% Measured at Baseline and Month 3(3 months)