NCT04696757已完成2 期
Non-OpeRative MANagement of Rectal Cancer Patients Who Had Clinical Complete Response After Pre-operative Chemo-raDiotherapY
Kangbuk Samsung Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
This study is a single-center, open, prospective, single-treatment trial (pilot study). This study aims to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer and to investigate the feasibility of non-surgical treatment.
详细描述
Indication:
- mid-to-lower rectal cancer was diagnosed histologically as adenocarcinoma in preoperative examination,
- the tumor was located at the lower boundary of the tumor spans the anorectal junction, and the clinical stage is stage 2 or 3, and
- clinical complete remission was confirmed after the treatment response evaluation at 8 weeks after completion of preoperative chemoradiotherapy according to MR/SFS and biopsy.
Aim:
- to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer
- to investigate the feasibility of non-surgical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical CR after pre-operative CRT for Rectal cancer
排除标准
- 未提供
研究组 & 干预措施
Cape
Experimental
Capecitabine without surgery
干预措施: Capecitabine (Drug)
结局指标
主要结局
DFS
时间窗: Duration from Pre-operative CRT
Disease-free survival
次要结局
未报告次要终点
研究者
Dong-Hoe Koo
Professor
Kangbuk Samsung Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
Racotumomab-alum cancer vaccine for solid tumors in pediatric patientsSarcomaeuroblastoma, Nephroblastoma, Ewing's Sarcomapediatric solid tumorsSarcoma, EwingWilms TumorNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeuroectodermal TumorsNeoplasms, NeuroepithelialNeoplasms, Glandular and EpithelialNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOsteosarcomaNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeuroblastomaRPCEC00000206Center of Molecular Immunology (CIM)10
招募中
4 期
A clinical trial to study the efficacy and safety of Ayurveda therapy protocol in the management of Covid-19 and its Post complicationsCTRI/2021/07/034937Pankajakasthuri herbal research foundation
已完成
Unknown
Controlled Clinical Therapy Pilot Study for the treatment of depression and anxiety in the context of post-acute cardiac and neurological rehabilitatioF32.1Moderate depressive episodeDRKS00033049Rehazentrum Oldenburg68
已完成
不适用
Prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Man.severe aortic valve stenosis / severely calcified aortic valve has caused a stenosis10046973NL-OMON55716CARDIAWAVE SA.15
进行中（未招募）
不适用
Monozentrische, offene Therapiestudie zur Behandlung von Psoriasis-Patienten ab vollendetem 18. Lebensjahr mit Fumaderm® in Kombination mit einer UVB-Therapie (311 nm) im intraindividuellen HalbseitenvergleichPsoriasis vulgarisEUCTR2006-000501-37-DETechnical University Carl-Gustav-Carus12