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

• ClinicalTrials.gov Identifier: NCT00687986
• Recruitment Status: Terminated
• First Posted: June 2, 2008
• Last Update Posted: March 17, 2022
• Sponsor: Amsterdam UMC, location VUmc
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Information provided by (Responsible Party): SSenan, Amsterdam UMC, location VUmc

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Locations

Netherlands

VU University Medical Center

Amsterdam, Netherlands, 1007 MB

Sponsors and Collaborators

Amsterdam UMC, location VUmc

ZonMw: The Netherlands Organisation for Health Research and Development

More Information

Publications:

Haasbeek CJ, Senan S, Smit EF, Paul MA, Slotman BJ, Lagerwaard FJ. Critical review of nonsurgical treatment options for stage I non-small cell lung cancer. Oncologist. 2008 Mar;13(3):309-19. doi: 10.1634/theoncologist.2007-0195.

Hurkmans CW, Cuijpers JP, Lagerwaard FJ, Widder J, van der Heide UA, Schuring D, Senan S. Recommendations 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. Radiat Oncol. 2009 Jan 12;4:1. doi: 10.1186/1748-717X-4-1.

Chang JY, Senan S, Paul MA, Mehran RJ, Louie AV, Balter P, Groen HJ, McRae SE, Widder J, Feng L, van den Borne BE, Munsell MF, Hurkmans C, Berry DA, van Werkhoven E, Kresl JJ, Dingemans AM, Dawood O, Haasbeek CJ, Carpenter LS, De Jaeger K, Komaki R, Slotman BJ, Smit EF, Roth JA. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Oncol. 2015 Jun;16(6):630-7. doi: 10.1016/S1470-2045(15)70168-3. Epub 2015 May 13. Erratum In: Lancet Oncol. 2015 Sep;16(9):e427.

Louie AV, van Werkhoven E, Chen H, Smit EF, Paul MA, Widder J, Groen HJ, van den Borne BE, De Jaeger K, Slotman BJ, Senan S. Patient reported outcomes following stereotactic ablative radiotherapy or surgery for stage IA non-small-cell lung cancer: Results from the ROSEL multicenter randomized trial. Radiother Oncol. 2015 Oct;117(1):44-8. doi: 10.1016/j.radonc.2015.08.011.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Park S, Kim HJ, Park IK, Kim YT, Kang CH. Stereotactic ablative radiotherapy versus surgery in older patients with stage I lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):74-80. doi: 10.1093/ejcts/ezab045.

• Responsible Party: SSenan, Principal investigator, Amsterdam UMC, location VUmc
• ClinicalTrials.gov Identifier: NCT00687986
• Other Study ID Numbers: ROSEL
• First Posted: June 2, 2008
• Last Update Posted: March 17, 2022
• Last Verified: March 2022

Keywords provided by SSenan, Amsterdam UMC, location VUmc:

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