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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014