Lung cancer
Conditions
Interventions
The standard arm is a primary surgical resection, and the experimental arm is stereotactic radiotherapy.
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 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; 3. 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; 4. 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; 5. Patient should be fit to undergo a complete surgical resection of the lesion in accordance with Dutch CBO guidelines [2004]; 6. Performance score of ECOG ≤ 2 before any treatment; 7. Able to comply with post-treatment follow-up; 8. Patients must sign and date a written Independent Ethics Committee approved informed consent form.
Exclusion criteria
Exclusion criteria: 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; 3. 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); 4. Concomitant treatment with any other experimental drug under investigation; 5. Pregnancy; 6. Men and women of child-bearing potential not using effective means of contraception for 6 months after treatment has been completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Local and regional control at 5 years; 2. Quality of life and treatment costs at 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival at 5 years; 2. Quality adjusted life years (QALYs) and total costs (both direct and indirect) at 2 years. | — |
Contacts
Public ContactS. Senan
Postbox 7057
Outcome results
None listed