A randomized clinical trial of surgery or radiosurgery (stereotactic radiotherapy) in patients with stage IA non-small cell lung cancer who are fit to undergo primary resectio

Phase 3

Completed

• Conditions: stage IA NSCLC; operable early-stage lung cancer; 10038666; 10024967; 10038737

• Registration Number: NL-OMON32289
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 960

Inclusion Criteria

Age * 18 years;Patients with a diagnosis of stage IA non-cell lung cancer diagnosed in accordance with Dutch CBO guidelines. 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. ;No evidence of regional or distant metastases on a standardized FDG-PET scan within 6 weeks of any protocol treatment .;Medial extension of tumours should be least 2 cm away from main and lobar bronchi, and also minimum of 1.5 cm from large peripheral blood vessels such as the aorta and main pulmonary artery. Lesions of at least 2 cm from the mediastinal pleura will be eligible if the responsible radiation oncologist judges that the specified normal tissue tolerance doses specified in the protocol will not be exceeded.;Patients should be fit to undergo both surgery and SRT. ;Patients who are judged by a multi-disciplinary team to have 2 primary lung tumors (on the basis of clinical, radiological, FDG-PET and/or cyto-pathology findings) are eligible for randomization provided that both surgery and SRT can be performed in accordance with protocol requirements.;Patient should be fit to undergo a complete surgical resection of the lesion in accordance with Dutch CBO guidelines [2004] ;Performance score of ECOG * 2 before any treatment.;Able to comply with post-treatment follow-up

Exclusion Criteria

Prior chemotherapy or radiotherapy for the present diagnosis of NSCLC. ;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.;Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).;Concomitant treatment with any other experimental drug under investigation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare local and regional control, quality of life and treatment costs at<br /><br>2- and 5-years, in patients with stage IA NSCLC who are randomized to either<br /><br>surgery or radiosurgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Overall survival, pulmonary function tests, quality adjusted life years<br /><br>(QALYs), total costs (both direct and indirect).</p><br>