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

This study has been terminated.
(Poor recruitment)
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00687986
First received: May 28, 2008
Last updated: April 4, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Lung Cancer
Radiation: stereotactic radiotherapy
Procedure: primary surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • local and regional control [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • quality adjusted life years (QALYs) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 960
Study Start Date: October 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687986

Locations
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1007 MB
Sponsors and Collaborators
VU University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Suresh Senan, MD, PhD VU University Medical Center
Principal Investigator: Egbert F Smit, MD, PhD VU University Medical Center
  More Information

Publications:
Responsible Party: Professor S SENAN, VU University Medical Center, De Boelelaan 1117, Postbox 7057, 1007 MB Amsterdam
ClinicalTrials.gov Identifier: NCT00687986     History of Changes
Other Study ID Numbers: ROSEL
Study First Received: May 28, 2008
Last Updated: April 4, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:
surgery
stereotactic radiotherapy
tumor control
quality of life

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014