In low-risk patients with stage I non-small cell lung cancer (NSCLC) surgical treatment with an anatomical resection is currently the standard of care.
For medically inoperable patients with stage I NSCLC, radiation therapy is currently the standard treatment. The latest generation of radiation therapy modalities is Stereotactic Body Radiation Therapy (SBRT).
In high-risk patients, minimal invasive surgery in terms of sublobar resection (wedge resection) with lymph node sampling is currently the recommended treatment approach for these patients, even though the evidence is limited. Additionally, SBRT is an alternative treatment option but the use in these patients is also based on weak evidence. So, it is highly warranted to compare these two treatment options in this group of patients in a randomized, controlled trial where selection bias can be eliminated. It is the specific aim of this study to provide such a trial allowing an evidence-based approach when deciding between surgery and SBRT as treatment for NSCLC in high-risk patients.
The STRADOS study (STereotactic RADiotherapy Or Surgery) is an open randomized, controlled national multicenter study in which high-risk patients with stage I non-small-cell lung cancer (NSCLC) are randomized to receive either surgical treatment with minimal invasive wedge resection with lymph node sampling, or SBRT.
The overall purpose of the study is to investigate the disease-free survival (DFS) after surgical treatment when compared to SBRT. The primary endpoint is DFS after 3 years. Secondary endpoint is quality of life after 1, 3, 6, 12 and 36 months. Tertiary endpoints are overall survival (OS) after 3 and 5 years; DFS after 5 years; re-admission adverse events and complications after 1, 3, 6, 12 and 36 months; health-care related costs within 12 and 36 months; PRO data - other than quality of life (QoL) (health condition, symptoms and functional level) after 1, 3, 6, 12 and 36 months and lung function test after 12 month.
Age ≥ 18 years
Biopsy-proven NSCLC
Diagnostic codes: DC34, DC 34.1, DC 34.2, DC 34.3 or DC 34.9
Clinical stage I NSCLC according to the 9th edition of TNM
Declared terminally ill or life expectancy shorter than one year.
Multifocal disease
PS ≥ 3
Centrally located tumors not eligible to SBRT
Parallel
Stereotactic radiation therapy intervention
RadiationThe SBRT planning technique is based on recommendations from the Advisory Committee on Radiation Oncology Practice (ACROP) guideline and the ICRU report 91: Prescribing, Recording and Reporting of Stereotactic Treatments with Small Photon Beams as implemented in the recommendations from the Radiotherapy Committee of Danish Oncology Lung Cancer Group. Planning should be guided by respiratory guided CT scans
Surgical intervention
Procedure/SurgeryPatients who are randomized to have surgery undergo a SWR via a minimal approach (VATS or RATS) during general anesthesia. Pre- and postoperative care and treatment is offered in accordance with local department guidelines. The surgery must be performed or supervised by a specialist in thoracic surgery. The operation is performed with the patient in lateral recumbent position. The surgeon decides the number of ports (1-4), and local analgesic is applied at the incision sites and/or as a nerve block. Additional pain management is registered and performed according to the local practice at the individual department. At the end of surgery, a chest tube is inserted in pleura through one of the ports, and the tube is connected to suction at levels decided by the treating surgeon. Patients in which minimal surgery is converted to thoracotomy are included in an intention-to-treat analysis.
Disease free survival (DFS)
• DFS of patients treated with either surgery (SWR) or SBRT after 3 years
Life quality
Quality of life after 1, 3, 6, 12 and 36 months PROs are collected from all patients before initiation of treatment (baseline measurements). As soon as the patient is diagnosed with stage I NSCLC and included in the study, a questionnaire will be distributed electronically to the patient using RedCap. When the patient visits the outpatient clinic to receive information concerning the diagnosis and treatment, the doctor informs the patient about the importance of the questionnaire and (if needed) how to fill it out electronically. European Quality of Life - 5 Dimensions (EQ-5D-5L): assess symptom or quality of life issues on a nummerical scale ranging from 1-5 and on a visual analog well being score ranging from 0-100
Life quality
Quality of life after 1, 3, 6, 12 and 36 months PROs are collected from all patients before initiation of treatment (baseline measurements). As soon as the patient is diagnosed with stage I NSCLC and included in the study, a questionnaire will be distributed electronically to the patient using RedCap. When the patient visits the outpatient clinic to receive information concerning the diagnosis and treatment, the doctor informs the patient about the importance of the questionnaire and (if needed) how to fill it out electronically. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): assess symptom or quality of life issues on a nummerical scale ranging from 1-4
Life quality
Quality of life after 1, 3, 6, 12 and 36 months PROs are collected from all patients before initiation of treatment (baseline measurements). As soon as the patient is diagnosed with stage I NSCLC and included in the study, a questionnaire will be distributed electronically to the patient using RedCap. When the patient visits the outpatient clinic to receive information concerning the diagnosis and treatment, the doctor informs the patient about the importance of the questionnaire and (if needed) how to fill it out electronically. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 29 (EORTC QLQ-LC29): assess symptom or quality of life issues on a nummerical scale ranging from 1-4
Overall survival
Overall survival after 3 and 5 years.
Loco-regional recurrence rate
The 2-, 3- and 5-year loco-regional recurrence rate
5-year disease free survival
The 5-year disease free survival
Re-admissions 1
Re-admissions following treatment, adverse reactions and complications ranked by Clavien-Dindo classification. Grade I-V.
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Aarhus University Hospital
Lead sponsor
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
Bispebjerg Hospital
Collaborator
University Hospital, Gentofte, Copenhagen
Collaborator
Vejle Hospital
Collaborator
Zealand University Hospital
Collaborator
Aalborg University
Collaborator
University of Aarhus
Collaborator
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