Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
研究概览
地位
条件
详细说明
Patients entering this study are offered the possibility of avoiding an extensive operation and a permanent stoma.
Over the past 2 years Vejle Hospital examined patients with rectal cancer during their course of treatment and we have developed a method to predict complete response.
Patients in this study are treated with chemotherapy and external irradiation supplemented with an endorectal boost (2 fractions). At the start of treatment and weeks 2, 4, and 6 of the treatment course an endoscopy is performed to evaluate the response. The final evaluation is performed 6 weeks after end of treatment. Patients with complete remission are offered observation. Patients with residual tumor are advised to be operated.
Follow-up is performed every 2 months the first year and every 3 months the second year. 2 follow-up visits are planned for the third year. A yearly follow-up is scheduled for the fourth and fifth year.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Vejle、丹麦、DK-7100
- Vejle Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Histopathologically verified adenocarcinoma in the rectum
- Planned APR or ultra low resection
- Primary resectable T2 or T3 tumor
- Distance from anus to lower edge of tumor ≤ 6 cm
- Suited for curative intended radiation and chemotherapy
- Accept taking of biopsy and blood samples for translational research
- Age ≥ 18 years
Normal function of bone marrow
- leukocytes ≥ 3 x 10^9/l
- thrombocytes ≥ 100
Normal liver function
- ALAT < 2.5 x upper normal value
- bilirubin < 2.5 x upper normal value
Renal function
- Serum creatinin < 1.5 x upper normal value
- Written and orally informed consent
Exclusion Criteria:
- Other malignant disease within the last 5 years apart from basocellular skin cancer and carcinoma in situ cervicis uteri
- Distant metastases
- Pregnant or breast feeding patients
学习计划
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Frequency of local recurrence
大体时间：1 year
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1 year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Frequency of cumulative local recurrence
大体时间：Up to 5 years
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Up to 5 years
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Frequency of distant metastases verified by planned PET/CT scans
大体时间：Up to 5 years.
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Up to 5 years.
|
|
Overall survival
大体时间：Up to 5 years.
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Up to 5 years.
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合作者和调查者
调查人员
- 首席研究员：Anders Jakobsen, DMSc、Vejle Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.