ACTRN12615000381583进行中(未招募)未知
A study to evaluate the use of circulating tumour DNA to guide adjuvant chemotherapy on recurrence-free survival in patients with stage II Colon or rectal cancer.
Walter and Eliza Hall Institute0 个研究点目标入组 459 人开始时间: 2015年4月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 459
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •1. Subjects with curatively resected stage II (T3-4, N0M0) colon or rectal cancer.
- •2. Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy or radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy. All rectal cancer patients included in the trial must have had TME type surgery with negative (R0) resection margins.
- •3. A representative paraffin embedded tumour sample is avaiable for molecular testing.
- •4. Fit for adjuvant chemotherapy.
- •5. ECOG performance status 0-2.
- •6. Patients that are accessible for follow up.
- •7. CT C/A/P within 8 weeks demonstrating no metastatic disease.
排除标准
- •1. History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix.
- •2. Patients with multiple primary colorectal cancers
- •3. Patients treated with neoadjuvant chemo-radiation.
- •4. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol.
研究者
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