Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer

Study Overview
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Brief Summary
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The standard treatment for an early stage I lung cancer is surgery. However, surgery can be associated with complications and long-term impairment of the quality of life of patients. Stereotactic radiotherapy (SRT) is a outpatient technique which allows for local control rates that are comparable to those achieved using surgery. In this study, patients with stage IA non-small cell lung cancer will be randomized to either surgery or SRT in order to study the local and regional tumor control, quality of life and treatment costs at 2- and 5-years.

Official Title
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A Randomized Clinical Trial of Surgery Versus Radiosurgery (Stereotactic Radiotherapy) in Patients With Stage IA NSCLC Who Are Fit to Undergo Primary Resection

Conditions
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Lung Cancer

Intervention / Treatment
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* Radiation: stereotactic radiotherapy
* Procedure: primary surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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]. No evidence of regional or distant metastases on a standardized FDG-PET scan within 6 weeks of any protocol treatment . The medial extension of tumors 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 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 Patients must sign and date a written Independent Ethics Committee approved informed consent form. 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. Pregnancy Men and women of child-bearing potential not using effective means of contraception for 6 months after treatment has been completed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: primary surgery<br>primary surgical resection | Procedure: primary surgery<br>* an anatomical surgical resection with lymph node dissection<br>* Other names: operation;|
| Experimental: stereotactic radiotherapy<br>primary stereotactic radiotherapy | Radiation: stereotactic radiotherapy<br>* Either 3 fractions of 20 Gray or 5 fractions of 12 Gy<br>* Other names: radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local and regional control |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 
| quality adjusted life years (QALYs) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, stereotactic radiotherapy, tumor control, quality of life