Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer (NCT00687986) | Clinical Trial Compass
TerminatedPhase 3
Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer
Stopped: Poor recruitment
Netherlands22 participantsStarted 2008-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 Independen…