Phase 3
Completed N=222
Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00107172 ↗Enrolled (actual)
222
Serious AEs
5.4%
Results posted
Dec 2016
Primary outcomePrimary: Time to Local Recurrence — NA; NA years — p=0.98
◆ Published Evidence
Highly cited
115citations · ~10 / year
Impact of brachytherapy on local recurrence rates after sublobar resection: results from ACOSOG Z4032 (Alliance), a phase III randomized trial for high-risk operable non-small-cell lung cancer.
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.
Linked Publications (4)
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Impact of brachytherapy on local recurrence rates after sublobar resection: results from ACOSOG Z4032 (Alliance), a phase III randomized trial for high-risk operable non-small-cell lung cancer.
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Thirty- and ninety-day outcomes after sublobar resection with and without brachytherapy for non-small cell lung cancer: results from a multicenter phase III study.
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Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer: results from the ACOSOG Z4032 (Alliance) multicenter randomized trial.
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The impact of adjuvant brachytherapy with sublobar resection on pulmonary function and dyspnea in high-risk patients with operable disease: preliminary results from the American College of Surgeons Oncology Group Z4032 trial.
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 |
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)
Data sourced from ClinicalTrials.gov (NCT00107172) and the linked publication. 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. Informational only — not medical advice.