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

NCT00687986 | Terminated Phase 3 DMC

• 1 other identifier: ROSEL
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

surgery; stereotactic radiotherapy; tumor control; quality of life

Outcome Measures

Primary Outcomes (1)

• local and regional control

  5 years

Secondary Outcomes (2)

• Overall survival

  5 years

• quality adjusted life years (QALYs)

  2 years

Study Arms (2)

primary surgery

ACTIVE COMPARATOR

primary surgical resection

Procedure: primary surgery

stereotactic radiotherapy

EXPERIMENTAL

primary stereotactic radiotherapy

Radiation: stereotactic radiotherapy

Interventions

stereotactic radiotherapy RADIATION

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

Also known as: radiotherapy

stereotactic radiotherapy

primary surgery PROCEDURE

an anatomical surgical resection with lymph node dissection

Also known as: operation

primary surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, 1007 MB, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 18378542 BACKGROUND

• 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.

  PMID: 19138400 BACKGROUND

• 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.

  PMID: 25981812 BACKGROUND

• 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.

  PMID: 26492839 BACKGROUND

• 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.

  PMID: 33668061 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiosurgery; Radiotherapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

NL (1)