Sublobar Wedge Resection or Stereotactic Radiotherapy Treatment of High-risk Patients With Early-stage Lung Cancer - a Randomized, Controlled Trial The STRADOS Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 182
- 试验地点
- 4
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
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.
详细描述
BACKGROUND:
Lung cancer is the most frequently diagnosed cancer type worldwide with approximately 2.5 million new cases and 1.8 million deaths annually, making it a leading cause of cancer-related mortality. The incidence of early-stage lung cancer is increasing likely due factors such as incidental findings, screening, increased awareness and the introduction of cancer packages.
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 with sublobar resection known as surgical wedge resection (SWR) with lymph node sampling is currently the recommended treatment approach for these patients but based on weak evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •9th 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-
- •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:
- •FEV-1 = 51-60% and/or DLCO = 51-60%
- •Known pulmonary hypertension with PAP ≥40 mm Hg diagnosed < 6 months before inclusion
- •Known LVEF ≤ 40% diagnosed < 6 months before inclusion
排除标准
- •Declared terminally ill or life expectancy shorter than one year.
- •Multifocal disease
- •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)
研究组 & 干预措施
Surgical treatment
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.
干预措施: Surgical intervention (Procedure)
Stereotactic Body Radiation Therapy (SBRT)
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
干预措施: Stereotactic radiation therapy intervention (Radiation)
结局指标
主要结局
Disease free survival (DFS)
时间窗: 3 years
• DFS of patients treated with either surgery (SWR) or SBRT after 3 years
次要结局
- Life quality(1, 3, 6, 12 and 36 months)
研究者
Thomas Decker Christensen
Professor, consultant, MD, DMSc, PhD
Aarhus University Hospital