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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00687986
Recruitment Status : Terminated (Poor recruitment)
First Posted : June 2, 2008
Last Update Posted : March 17, 2022
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
SSenan, Amsterdam UMC, location VUmc

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: stereotactic radiotherapy Procedure: primary surgery Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. local and regional control [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
  2. quality adjusted life years (QALYs) [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

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

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VU University Medical Center
Amsterdam, Netherlands, 1007 MB
Sponsors and Collaborators
Amsterdam UMC, location VUmc
ZonMw: The Netherlands Organisation for Health Research and Development

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SSenan, Principal investigator, Amsterdam UMC, location VUmc
ClinicalTrials.gov Identifier: NCT00687986    
Other Study ID Numbers: ROSEL
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022
Keywords provided by SSenan, Amsterdam UMC, location VUmc:
stereotactic radiotherapy
tumor control
quality of life
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases