Status:
TERMINATED
Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 radi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00687986
Start Date
October 1 2008
End Date
February 1 2010
Last Update
March 17 2022
Active Locations (1)
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1
VU University Medical Center
Amsterdam, Netherlands, 1007 MB