Sublobar Wedge Resection or Stereotactic Radiotherapy Treatment of High-risk Patients With Early-stage Lung Cancer

NCT07432802 | Not Yet Recruiting DMC

• 1 other identifier: 1-10-72-205-25
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Lung Cancer (NSCLC)

Keywords

lung cancer; surgery; Stereotactic radiotherapy treatment; randomized

Outcome Measures

Primary Outcomes (1)

• Disease free survival (DFS)

  • DFS of patients treated with either surgery (SWR) or SBRT after 3 years

  3 years

Secondary Outcomes (3)

• Life quality

  1, 3, 6, 12 and 36 months

• Life quality

  1, 3, 6, 12 and 36 months

• Life quality

  1, 3, 6, 12 and 36 months

Other Outcomes (11)

• Overall survival

  3 and 5 years

• Loco-regional recurrence rate

  2, 3 and 5 years

• 5-year disease free survival

  5 years

Study Arms (2)

Surgical treatment

ACTIVE COMPARATOR

Patients 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.

Procedure: Surgical intervention

Stereotactic Body Radiation Therapy (SBRT)

EXPERIMENTAL

The 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

Radiation: Stereotactic radiation therapy intervention

Interventions

Surgical intervention PROCEDURE

Patients 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.

Surgical treatment

Stereotactic radiation therapy intervention RADIATION

The 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

Stereotactic Body Radiation Therapy (SBRT)

Eligibility Criteria

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

You may qualify if:

• 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
• Performed diagnostic PET-CT and supplementary invasive procedures for staging purposes in accordance with the Danish national reference program for the staging and treatment of lung cancer (30)
• th edition TNM staging: cT1aN0M0, cT1b-cN0M0, cT1cN0M0 and cT2aN0M0 (clinical stage I)
• Tumor is localized in the outer third of the lung and considered technically resectable by SWR, as well as treatable with peripheral SBRT when assessed during MDT conference
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0-2.
• Preoperative pulmonary function test according to national guidelines performed within 6 weeks before the MDT conference
• Patient fulfills the "high-risk patient" criteria outlined:
• A high-risk patient is a patient that fulfills at minimum one of the main-risk criteria and/or two of the secondary criteria:
• Main criteria:
• FEV-1 ≤ 50% and/or
• DLCO ≤ 50%
• Secondary criteria:

You may not qualify if:

• Declared terminally ill or life expectancy shorter than one year.
• Multifocal disease
• PS ≥ 3
• Centrally located tumors not eligible to SBRT
• Previous ipsilateral lung surgery
• Pregnancy or breastfeeding.
• Inability to understand oral and written informed consent
• Intravenous substance abuse or severe alcohol abuse (\> 25 units per week)
• Not amendable for surgery in general anesthetic
• Previous radiotherapy to the thorax, which may limit the feasibility or increase the risk of stereotactic reirradiation due to cumulative dose constraints and potential toxicity
• Diagnosed with Interstitial lung disease (ILD)

Sponsors & Collaborators

• Aarhus University Hospital: lead
• 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

Study Sites (4)

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Aalborg University Hospital

Aalborg, Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Thomas D Christensen, MD, DMSc, PhD.

  Department of Cardiothoracic Surgery & Department of Clinical Medicine. Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N. DK-Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas D Christensen, MD, DMSc, PhD.

CONTACT

29418528; tdc@clin.au.dk

Christian B Larsen, MD, PhD.

CONTACT

3023 1114; Christian.b.lauersen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant, MD, DMSc, PhD

Model Details: Patients will be randomized 1:1 to either: * Surgery - minimal invasive SWR and lymph node sampling * SBRT Block restricted randomization with varying block sizes will be used to ensure an equal number of patients in both groups. The randomization will include stratification for treatment centers (Copenhagen University Hospital, Aarhus University Hospital, Odense University Hospital (including Vejle Hospital) and Aalborg University Hospital). Eligible patients who meet the inclusion criteria will be offered to participate in this research project. Information is given to the patient by the responsible pulmonologist at the local department of pulmonology following the MDT in collaboration with the regional oncologists / thoracic surgeons. If the patient accepts inclusion, randomization is performed via a web-based randomization program, which is constructed in RedCap (Research Electronic Data Capture), (REDCap Consortium, Vanderbilt University Medical Center, Tennessee, USA) and housed

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: February 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 September 2026
• Access Criteria: By contacting the principal investigator

Locations

DK (4)