Lung Cancer
Conditions
Keywords
surgery, stereotactic radiotherapy, tumor control, quality of life
Brief 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.
Interventions
RADIATIONstereotactic radiotherapy
Either 3 fractions of 20 Gray or 5 fractions of 12 Gy
PROCEDUREprimary surgery
an anatomical surgical resection with lymph node dissection
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local and regional control | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 5 years |
| quality adjusted life years (QALYs) | 2 years |
Countries
Netherlands
Outcome results
None listed