Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer (ROSEL)
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|ClinicalTrials.gov Identifier: NCT00687986|
Recruitment Status : Terminated (Poor recruitment)
First Posted : June 2, 2008
Last Update Posted : March 17, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: stereotactic radiotherapy Procedure: primary surgery||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Clinical Trial of Surgery Versus Radiosurgery (Stereotactic Radiotherapy) in Patients With Stage IA NSCLC Who Are Fit to Undergo Primary Resection|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Active Comparator: primary surgery
primary surgical resection
Procedure: primary surgery
an anatomical surgical resection with lymph node dissection
Other Name: operation
Experimental: stereotactic radiotherapy
primary stereotactic radiotherapy
Radiation: stereotactic radiotherapy
Either 3 fractions of 20 Gray or 5 fractions of 12 Gy
Other Name: radiotherapy
- local and regional control [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- quality adjusted life years (QALYs) [ Time Frame: 2 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with a cytological or histological diagnosis of stage IA non-cell lung cancer diagnosed in accordance with Dutch CBO guidelines . 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 
- 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.
- 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.
- Men and women of child-bearing potential not using effective means of contraception for 6 months after treatment has been completed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687986
|VU University Medical Center|
|Amsterdam, Netherlands, 1007 MB|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||SSenan, Principal investigator, Amsterdam UMC, location VUmc|
|Other Study ID Numbers:||
|First Posted:||June 2, 2008 Key Record Dates|
|Last Update Posted:||March 17, 2022|
|Last Verified:||March 2022|
quality of life
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases