NCT05253144已完成不适用
Rational-MCC: A Randomised Phase III Multi-centre Trial Comparing Radical Surgery and Radical Radiotherapy as First Definitive Treatment for Primary MCC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 14
- 主要终点
- Time to loco-regional failure
研究概览
简要总结
A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC
详细描述
A randomised phase III multi-centre trial comparing radical surgery and radical radiotherapy as first definitive treatment for primary MCC with an observational study for patients ineligible for the randomised trial.
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
- •General Inclusion Criteria for All Patients:
- •Patients newly diagnosed with histologically-proven MCC (either primary and/or regional nodal disease)
- •Completion of clinical and radiological staging investigations, including CT imaging (or other modality) of regional nodal basin(s) and major viscera (and SLNB if clinically appropriate) to identify regional and distant metastases
- •No confirmed distant metastases beyond the regional nodal basin (i.e. not stage IV disease)
- •Suitable for radical treatment to achieve disease control
- •Able to give valid informed consent
- •Consent for collection of data and tissue samples and follow up
- •Life expectancy six months or greater in relation to general fitness and co-morbidities
- •Additional Inclusion Criteria for Rational Compare:
- •Patients newly diagnosed with histologically-proven primary MCC
- •In the opinion of the SSMDT, the primary MCC can be encompassed both within a wide surgical margin and within a radiotherapy field, and the SSMDT is in equipoise regarding WLE or radiotherapy as first treatment
- •A minimum margin of 1 cm surrounding the MCC achievable by either radiotherapy or surgery
- •Consent for randomisation into Rational Compare
排除标准
- •The primary MCC has already been treated radically with WLE (surgical margins >10 mm) or radiotherapy
- •Intended use of regional or systemic chemotherapy for MCC (including molecularly targeted agents and immunotherapy)
结局指标
主要结局
Time to loco-regional failure
时间窗: Time from randomisation to 3 years
The time to loco regional failure for all patients is the time from randomisation to loco-regional treatment failure
次要结局
- Patient survival(Time from randomisation to 3 years)
- Time to 'local failure'-the time from randomisation to macroscopic persistence, progression or recurrence between the primary site and regional nodal basin(s)(Time from randomisation to 3 years)
- Time to regional nodal failure(Time from randomisation to 3 years)
- Time to distant progression(Time from randomisation to 3 years)
- Patient Progression free survival(Time from randomisation to 3 years)
- Quality of life assessed by questionnaires(Time from randomisation to 3 years)
- The proportion of patients alive and free of loco-regional disease(Time from randomisation to 3 years)
研究者
研究点 (14)
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