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TerminatedNCT00687986ROSELUpdated Mar 17, 2022

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

A Phase 3 interventional study of stereotactic radiotherapy and primary surgery in Lung Cancer, sponsored by Amsterdam UMC, location VUmc. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by Amsterdam UMC, location VUmc · Phase 3, Interventional, and Treatment

Why this study was terminated
Poor recruitment
Phase
Phase 3
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Lung Cancer

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Keywords

  • surgery
  • stereotactic radiotherapy
  • tumor control
  • quality of life
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 22 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Active comparator
    primary surgery

    primary surgical resection

    Procedure: primary surgery

  • Experimental
    stereotactic radiotherapy

    primary stereotactic radiotherapy

    Radiation: stereotactic radiotherapy

Interventions

  • Radiationstereotactic radiotherapy

    Either 3 fractions of 20 Gray or 5 fractions of 12 Gy

    Also known as: radiotherapy

  • Procedureprimary surgery

    an anatomical surgical resection with lymph node dissection

    Also known as: operation

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What researchers measure

Primary outcomes

  1. local and regional control

    Time frame: 5 years

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

  2. quality adjusted life years (QALYs)

    Time frame: 2 years

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Study locations

1 site
  • VU University Medical Center
    Amsterdam, 1007 MB, Netherlands
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References and documents

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. PubMed 18378542 ↗
  • 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. PubMed 19138400 ↗
  • 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. doi: 10.1016/S1470-2045(15)00238-7. PubMed 25981812 ↗
  • 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. PubMed 26492839 ↗
  • 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. PubMed 33668061 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00687986
Lead sponsor
Amsterdam UMC, location VUmc
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
Responsible party
SSenan (Principal investigator, Amsterdam UMC, location VUmc) — Principal investigator
First posted
Jun 2, 2008
Start date
Oct 2008
Primary completion
Feb 2010
Completion
Feb 2010
Last update
Mar 17, 2022

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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