跳至主要内容
临床试验/NCT02040272
NCT02040272Unknown不适用

Mesothelioma and Radical Surgery 2: a Multicentre Randomised Trial Comparing (Extended) Pleurectomy Decortication Versus no (Extended) Pleurectomy Decortication for Patients With Malignant Pleural Mesothelioma (Mars 2).

Royal Brompton & Harefield NHS Foundation Trust24 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
328
试验地点
24
主要终点
Survival

研究概览

简要总结

Mesothelioma is a cancer of the thin membrane that lines the chest and abdomen. Around 2500 people in the UK are diagnosed with mesothelioma each year and the median survival is approximately 8.5 months. Exposure to asbestos is the most common cause although the cancer does not usually become apparent until 40-60 years after exposure. Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) is undertaken. However, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients. The aim of the MARS2 study is to compare surgery - (extended) pleurectomy decortication - with no surgery with respect to overall survival, cost-effectiveness and quality of life. Patients will be followed up by phone at regular intervals for 2 years. Patients will be asked to complete and return a Quality of Life Questionnaire at these time points.

MARS 2 also includes an optional 'Information study', where consenting patients may be interviewed or have their consultations audio-recorded. The aim of the Information study is to explore how a patient makes a decision to take part in research or not, with the overall aim of improving recruitment to clinical trials.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Surgery

Experimental

(Extended) pleurectomy decortication

干预措施: (Extended) pleurectomy decortication (Procedure)

no surgery

No Intervention

no surgery

结局指标

主要结局

Survival

时间窗: 24 months

The time from randomisation to death will be measured and date of death will be collected on purposely designed case report forms.

次要结局

  • Progression free survival to two years(24 months)
  • Health Related Quality of Life: EORTC QLQ-C30 (questionnaire) to two years(24 months)
  • Serious adverse health events to two years after randomisation(24 months)
  • Resource and health service use to two years and during initial surgical admission for surgical arm(24 months and during initial surgical admission for surgical arm)
  • Health Related Quality of Life: EQ-5D-5L (questionnaire) to two years(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (24)

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