A Randomized Clinical Trial of Surgery Versus Radiosurgery (Stereotactic Radiotherapy) in Patients With Stage IA NSCLC Who Are Fit to Undergo Primary Resection
- Patients with a cytological or histological 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 [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 
- 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
- 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
- Concomitant treatment with any other experimental drug under investigation.
- Men and women of child-bearing potential not using effective means of contraception
for 6 months after treatment has been completed.