NCT00597311Unknown3 期
Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- 5 years overall and disease free survival
研究概览
简要总结
Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge
- •less than 80 years old
- •no other cancer during 5 years period
- •compensate cardiovascular, pulmonary, hepatic and renal functions.
排除标准
- •stage I or IV rectal cancer
- •other cancer in 5 years period
- •radiotherapy or chemotherapy in anamnesis
- •not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
- •pregnancy or baby feeding
结局指标
主要结局
5 years overall and disease free survival
时间窗: 5 years
recurrence rate
时间窗: 5 years
次要结局
- pathological "complete response" and downstaging rates(5 years)
- Impact on sphincter sparing operation rates(5 years)
- morbidity and mortality rates(5 years)
- Impact on quality of surgical resection(5 years)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment TrialEsophageal NeoplasmsNCT00907543Richard Malthaner96
尚未招募
2 期
Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal CancerRectal Neoplasms MalignantRadiotherapyNCT05484024Chinese Academy of Medical Sciences588
已完成
3 期
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy With 5-Fluorouracil and Oxaliplatin Versus 5-Fluorouracil Alone in Rectal CancerRectal NeoplasmsNCT00349076University of Erlangen-Nürnberg Medical School1,256
Unknown
2 期
Preoperative Chemoradiotherapy Versus Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node MetastasesNon-small Cell Lung CancerNCT01187290Shanghai Jiao Tong University School of Medicine80
招募中
2 期
Preoperative Chemoradiotherapy With CApecitabine and Temozolomide in MGMT Silenced, MSS, Locally Advanced RecTal CancerRectal CancerNCT05136326Fondazione IRCCS Istituto Nazionale dei Tumori, Milano21