ACOSOG Z4099/ RTOG 1021 A randomized phase III study of sublobular resection (+/- brachytherapy) versus stereotactic body radiation therapy in high risk patients with stage I non-small cel lung cancer (NSCLC)
Phase 3
Withdrawn
- Conditions
- lung cancerLung carcinoma10038666
- Registration Number
- NL-OMON36861
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Age: 18 years or older
ECOG performance status of 0, 1 or 2
Patients at high risk for surgery (see protocol for criteria)
Lung nodule suspicious for NSCLC (biopsy confirmation is strongly recommended)
Clinical stage Ia or Ib, no evidence of metastases
All clinically suspicious mediastinal lymph nodes confirmed negative
Tumor verified by thoracic surgeon to be in location that permits sublobar resection
Exclusion Criteria
Evidence of metastases
Tumor >2 cm of bronchial tree
Prior intrathoracal radiotherapy
Previous chemotherapy or surgery for lungcancer treated on this protocol
Pregnant or lactating
Invasive cancer < 3 years prior to registration (exception, non melanoma skin cancer or in-situ cancer)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To ascertain whether patients treated by SBRT have a 3-year overall survival<br /><br>(OS) rate that is no more than 10% less than patients treated with SR.</p><br>
- Secondary Outcome Measures
Name Time Method