A Randomized Clinical Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer (ROSEL).
- Conditions
- ung cancerstage Isurgery, stereotactic radiotherapy
- Registration Number
- NL-OMON25182
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Recommendations for implementing stereotactic radiotherapy in peripheral stage IA non-small cell lung cancer: report from the Quality Assurance Working Party of the randomised phase III ROSEL study. Hurkmans CW, Cuijpers JP, Lagerwaard FJ, Widder J, van der Heide UA, Schuring D, Senan S. Radiat Oncol. 2009 Jan 12;4:1
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 960
1. Patients with a cytological or histological diagnosis of stage IA non-cell lung cancer diagnosed in accordance with Dutch CBO guidelines [2004]. When no pathological diagnosis is available, a patient with a new or growing pulmonary lesion with radiological features consistent with malignancy AND a lesion showing uptake on a FDG-PET scan will be eligible [Herder 2005];
2. No evidence of regional or distant metastases on a standardized FDG-PET scan within 6 weeks of any protocol treatment;
1. Prior chemotherapy or radiotherapy for the present diagnosis of NSCLC;
2. History of any active malignancy (other than NSCLC) unless treated more than 3 years with curative intent and no recurrence, with the exception of non-melanoma skin cancers or in-situ cervical cancers;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Local and regional control at 5 years;<br /><br>2. Quality of life and treatment costs at 2 years.
- Secondary Outcome Measures
Name Time Method 1. Overall survival at 5 years;<br /><br>2. Quality adjusted life years (QALYs) and total costs (both direct and indirect) at 2 years.