ISRCTN44351742已完成未知
Mesothelioma and Radical Surgery 2: a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decortication for patients with malignant pleural mesothelioma.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 335
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32873681/ protocol (added 04/09/2020) 2024 Other publications in https://doi.org/10.1136/bmjopen-2023-079108 results from a complex recruitment intervention within the Mesothelioma and Radical Surgery 2 (MARS 2) study (added 20/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patient may enter study if ALL of the following apply:
- •1. Aged 16 years or older
- •2. Tissue (cytology or histology) confirmed epithelioid, sarcomatoid or biphasic mesothelioma*
- •3. Disease confined to one hemi-thorax based on CT assessment
- •4. Disease deemed surgically resectable**
- •5. Fit for surgery**
- •6. Capacity to provide written informed consent to participate in the trial
- •*The diagnosis” of mesothelioma is based on cytology and / or histopathology results as reviewed by MDT to be of sufficient certainty to recommend chemotherapy as treatment.
- •**To be confirmed by a surgeon at a MARS 2 surgical site (added 29/08/2019)
排除标准
- •Current inclusion criteria as of 29/08/2019:
- •Patient may not enter study if ANY of the following apply:
- •1. Severe shortness of breath (this is defined as an Eastern Cooperative Oncology Group (ECOG) status >= 2, or if lung function tests are performed: pre-operative forced expiratory volume after one second (FEV1) or transfer factor of the lung for carbon monoxide (TLco) less than 20%);
- •2. Serious concomitant disorder that would compromise participant safety during surgery (e.g. evidence of end organ failure)
- •3. Severe heart failure (this is defined as NYHA III or IV or if an echocardiogram is performed an ejection fraction less than 30%)
- •4. End stage kidney failure requiring dialysis
- •5. Liver failure (e.g. encephalopathy and/or coagulation abnormalities)
- •6. Prisoner
- •7. Patient lacks capacity to consent
- •8. Existing co-enrolment in another interventional clinical trial that aims to improve survival
- •Previous exclusion criteria:
- •Patient may not enter study if ANY of the following apply:
- •1. Severe shortness of breath (Eastern Cooperative Oncology Group (ECOG) status >= 2, pre-operative forced expiratory volume after one second (FEV1) or transfer factor of the lung for carbon monoxide (TLco) less than 20%);
- •2. Serious concomitant disorder that would compromise participant safety during surgery (e.g. evidence of end organ failure)
- •3. Severe heart failure (EF less than 30% by echocardiogram)
- •4. End stage kidney failure requiring dialysis
- •5. Liver failure (e.g. encephalopathy and/or coagulation abnormalities)
- •6. Prisoner
- •7. Patient lacks capacity to consent
- •8. Co-enrolment in another interventional clinical trial
研究者
相似试验
进行中（未招募）
2 期
Radiotherapy combined with immunotherapy in metastatic non-small cell lung cancer patientsAdvanced non-small cell lung cancer, stage IVMalignant neoplasm the lung, non-small cell lung cancerCancerISRCTN49817477Maastricht University88
已完成
不适用
asal airway obstruction study - NAIROSDeviated septumEar, Nose and ThroatISRCTN16168569ewcastle Upon Tyne NHS Foundation Trust378
已完成
不适用
A multicentre pragmatic clinical investigation to assess the efficacy of TransiCap MRI marker devices in magnetic resonance imaging when used to determine whole gut transit time, and inform treatment selection in paediatric constipatioPaediatric constipationDigestive SystemConstipationISRCTN42273449ottingham University Hospitals NHS Trust436
已完成
不适用
Surgical vs non-surgical treatment of LC1 pelvic injuriesPelvis fractureInjury, Occupational Diseases, PoisoningISRCTN10649958orth Bristol NHS Trust37
已完成
不适用
PUrE: percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stonesower pole kidney stonesUrological and Genital DiseasesISRCTN98970319niversity of Aberdeen (UK)625