Hemithoracic Irradiation With Proton Therapy in Malignant Pleural Mesothelioma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 30
- 主要终点
- Progression free survival
研究概览
简要总结
Phase III randomised-controlled trial for patients with unilateral malignant pleural mesothelioma (MPM).
详细描述
Study design: Randomised phase III clinical trial for patients with unilateral MPM.
Primary endpoint: Progression free survival (PFS) and overall survival (OS), defined as the time from randomisation to the date of progression and death from any cause.
Secondary Endpoints: Safety and Tolerability, Health related Quality of Life (QOL): EuroQoL EQ-5D-3L, Locoregional Control.
Randomisation and stratification: 1:1 randomisation. Patients with be stratified for histology (epithelioid versus non-epithelioid), potential PBT centre (UCLH or The Christie)
, laterality (left or right sided) and time since diagnosis (<1 year or > 1 year)
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
- •Patients ≥18 years of age, with biopsy confirmed MPM and histological subtyping (epithelioid or non-epithelioid)
- •N0 or N1 and M0 disease
- •Written informed consent
- •Patient and local/regional MDT opt for active surveillance and deferral of SACT until clinical or radiological progression
- •WHO Performance Status 0-1
- •Disease confined to one hemithorax based on CT assessment
- •Adequate pulmonary function
- •≥ 40% predicted post-FEV1;
- •≥ 40% predicted DLCO/TLCO
- •Agreement to travel to either proton beam therapy centres (i.e. UCLH or The Christie) if randomised to arm 2
- •Agreement to be followed up at a local HIT-Meso trial site
- •Patient likely able to complete PBT planning based on local assessment
排除标准
- •Presence of metastatic or contralateral disease
- •Cytological diagnosis and/or undetermined histological subtype
- •Prior thoracic radiotherapy, chemotherapy, immunotherapy for MPM
- •Prior radical surgery for MPM (extrapleural pneumonectomy or extended pleurectomy decortication or pleurectomy decortication)
- •Initial systemic therapy or surgery is required and the patient and local/regional MDT do not opt for active surveillance
- •Involvement of contralateral or supraclavicular lymph nodes
- •T4 disease with invasion of the myocardium
- •N2 and/or M1 disease
- •Presence of new effusion that is not amenable to drainage
- •WHO Performance Status ≥ 2
- •Women who are pregnant or breast feeding
- •Current or previous malignant disease which may impact on the patient's life expectancy
- •Patient fitted with a pacemaker or implantable cardioverter-defibrillator (ICD)\
- •Diagnosis of clinically significant interstitial lung disease (ILD), excluding mild fibrosis or incidental findings
- •Chronic non-malignant disease with an estimated three-year survival rate of less than 20%
- •Patient with prior thoracic / abdominal radiotherapy for malignancy who was not discussed with sponsor before recruitment
研究组 & 干预措施
Standard of care
MPM participants who are on the standard of care watch and wait approach i.e. immediate treatment not suitable. Participants will have follow-up for 2 years (3 monthly in year 1, 4 monthly in year 2).
Proton beam therapy
MPM participants to receive 5 weeks of proton beam therapy to the hemithorax. Following completion of treatment participants will have follow-up at the referring centre for 2 years (3 monthly in year 1, 4 monthly in year 2).
干预措施: Proton beam therapy (Radiation)
结局指标
主要结局
Progression free survival
时间窗: From randomisation up to 2 years of follow up
Defined as the time from randomisation to the date of disease progression
Overall survival
时间窗: From randomisation up to 2 years of follow up
defined as the time from randomisation to the date of death from any cause.
次要结局
- Number of PBT-related adverse events as assessed by CTCAE v5.0(From start of PBT up to 2 years of follow up, for long term effects)
- Measurement of costs in economic evaluations using iMTA Valuation of Informal Care (iVICQ) questionnaire(From randomisation up to 2 years of follow up)
- Participant reported healthcare resource use from information collected on Client Service Receipt Inventory (CSRI)(From randomisation up to 2 years of follow up)
- The EORTC quality of life questionnaire (QLQ), EORTC QLQ-C30 score, scale of 0-100.(From randomisation up to 2 years of follow up)
- ED-5D-5L score(From randomisation up to 2 years of follow up)