NCT05055635招募中2 期
ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Local control
研究概览
简要总结
This protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). The over-all aim is to improve local tumor control with acceptable side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Recurrent anal cancer
- •Bioptically verified (squamous cell carcinoma)
- •Available dose plan from primary radiotherapy
- •Previous RT (>30Gy EQD2)
- •Evaluated in MDT-conferences (Herlev, Aarhus)
- •Age>18 years
- •Adequate organ function
- •Written informed consent
排除标准
- •Distant metastases deemed without curative intended treatment options (PET-CT)
- •Unable to undergo MRI, PET-CT
- •Inability to attend full course radiotherapy and follow up in the outpatient clinic.
结局指标
主要结局
Local control
时间窗: 12 months
MRI
次要结局
- Local re-recurrence(6 and 24 months)
- Summed radiotherapy dose volume to organs at risk and correlation to toxicities(up to 6 weeks, 1 year, 3 year)
- To investigate 30-day surgical overall morbidity(30-day)
- Translational research(baseline, end of therapy, 1 year)
- Quality of life assessment(up to 6 weeks, 1 year, 3 year)
- Toxicity(up to 6 weeks, 1 year, 3 year)
- Progression free survival(3-5 year FU)
- Overall survival(3-5 year FU)
- Pathological evaluation of R0, R1 or R2 resection(6 months)
- To investigate 6-month surgical site morbidity(6 months)
研究者
研究点 (2)
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