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A Randomized Clinical Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer (ROSEL).


- candidate number5766
- NTR NumberNTR1820
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mei-2009
- Secondary IDsNCT00687986  Clinicaltrials.gov
- Public TitleA Randomized Clinical Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer (ROSEL).
- Scientific TitleA Randomized Clinical Trial of Surgery Versus Radiosurgery (Stereotactic Radiotherapy) in Patients With Stage IA NSCLC Who Are Fit to Undergo Primary Resection.
- ACRONYMROSEL
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedLung cancer
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-okt-2008
- planned closingdate1-dec-2013
- Target number of participants960
- InterventionsThe standard arm is a primary surgical resection, and the experimental arm is stereotactic radiotherapy.
- Primary outcome1. Local and regional control at 5 years;
2. Quality of life and treatment costs at 2 years.
- Secondary outcome1. Overall survival at 5 years;
2. Quality adjusted life years (QALYs) and total costs (both direct and indirect) at 2 years.
- TimepointsAt 2 years and 5 years.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf.dr. S. Senan
- CONTACT for SCIENTIFIC QUERIESProf.dr. S. Senan
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsRecommendations for implementing stereotactic radiotherapy in peripheral stage IA non-small cell lung cancer: report from the Quality Assurance Working Party of the randomised phase III ROSEL study. Hurkmans CW, Cuijpers JP, Lagerwaard FJ, Widder J, van der Heide UA, Schuring D, Senan S. Radiat Oncol. 2009 Jan 12;4:1
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-mei-2009 - 30-sep-2009


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