NCT04695782招募中2 期
Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- R0-resection
研究概览
简要总结
Study design:
A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer.
Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.
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
- •• Locally recurrent rectal cancer.
- •Bioptically verified (adenocarcinoma )
- •Available dose plan from primary radiotherapy
- •Previous pelvic RT (>30Gy EQD2)
- •Evaluated in MDT-conferences (Herlev, Aarhus)
- •Age>18 years
- •Adequate organ function
- •Informed consent
排除标准
- •Non-resectable distant metastases (PET-CT)
- •Unable to undergo MRI, PET-CT
- •Inability to attend full course radiotherapy and follow up in the out patient clinic.
研究组 & 干预措施
Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily
Experimental
干预措施: Pencil beam proton radiotherapy (Radiation)
Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily
Experimental
干预措施: Pencil beam proton radiotherapy (Radiation)
结局指标
主要结局
R0-resection
时间窗: 5-6 years
Neo-adjuvant treatment: Rate of pathological complete resection (R0)
1-year local control
时间窗: 6-7 years
Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.
次要结局
- Local recurrence(6-8 years)
- Toxicity(5-7 years)
- Patient reported outcomes(5-7 year)
- Disease free survival(10 years)
- Overall survival(10 years)
研究者
研究点 (1)
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