Phase 3 N=222 Randomized Treatment

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

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00107172 ↗

Enrolled (actual)

222

Serious AEs

5.4%

Results posted

Dec 2016

Primary outcome: Primary: Time to Local Recurrence — NA; NA years — p=0.98

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: surgery (Procedure); brachytherapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alliance for Clinical Trials in Oncology
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Local Recurrence	NA; NA	0.98
SECONDARY Overall Survival (OS)	5.3; 4.7	0.75
SECONDARY Number of Participants Reported Local Recurrence at 3 Years	14; 13	—
SECONDARY Number of Participants Reported Regional Recurrence at 3 Years	8; 9	—
SECONDARY Number of Participants Reported Distant Recurrence at 3 Years	10; 12	—
SECONDARY Mortality Rates at 30- and 90-day After Sublobar Resection	0.9; 1.9; 2.6; 2.8	—
SECONDARY Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection	29; 33; 34; 40	0.37
SECONDARY Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection	17; 4; 22; 6	0.35
SECONDARY Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24	43.2; 41.8; 51.4; 50.5; 43.2; 42.4	—
SECONDARY Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24	72.9; 70.0; 75.8; 69.2; 72.5; 72.1	—
SECONDARY FEV1% Measured at Baseline and Month 3	49; 51; 53; 53	0.03 sig
SECONDARY DLCO% Measured at Baseline and Month 3	46; 46; 48; 43	0.38

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.

Eligibility Criteria

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 = = 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) = 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00107172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.