Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer (PREPARE)
2017年9月12日 更新者：Sun Young Kim、National Cancer Center, Korea
A Randomized Phase II Trial of Preoperative Chemoradiation (Preop CRT) Followed by CapOx (Capecitabine Plus Oxaliplatin) Versus Preop CRT Alone for Locally Advanced Rectal Cancer (LARC)
The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery.
But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence.
This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.
研究概览
详细说明
Downstaging rate with CRT using fluoropyrimidine monotherapy is usually 30-40%.In MRI-defined high-risk patients, downstaging rate with conventional fluoropyrimidine-based monotherapy with radiation has not been shown.
We assume that the downstaging rate of chemoradiation arm (control arm) would be 30%, and that addition of CapOx after CRT (experimental arm) may increase downstaging rate 30% to 50%.
A sample size of 52 patients per group is needed have 85% power to detect downstaging rate = 50% as compared to 30% with type I error rate of 15%.
We will perform one interim futility analysis when half of the patients are recruited and evaluated for the primary endpoint.
O'Brien-Fleming boundary will be considered.
Therefore, when 26 patients per arm are evaluated, the interim futility analysis will be performed, and when the Z score at the interim is less than -0.09192 (one-sided p-value greater than 0.5366192), the study will be stopped for futility.
Considering 5% follow-up loss, a sample size of 55 per arm (a total of 110 patients) will be studied.
研究类型
介入性
注册 (实际的)
110
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Anyang、大韩民国
- Hallym University Sacred Heart Hospital
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Gangneung、大韩民国
- Gangneung Asan Hospital
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Seoul、大韩民国、03722
- Severance Hospital
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Seoul、大韩民国、05505
- Asan Medical Center
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Seoul、大韩民国、06973
- Chung-Ang University Hospital
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Gyeonggi-do
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Goyang、Gyeonggi-do、大韩民国、410-769
- National Cancer Center
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Seongnam、Gyeonggi-do、大韩民国、13620
- Seoul National University Bundang Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- histologically confirmed adenocarcinoma of the rectum
- distal margin of tumor located from 0 to 12 cm from anal verge measured by digital rectal examination
high risk clinical stage II or III in MRI (satisfying at least one of the followings)
- circumferential resection margin < 1 mm involved
- low-lying tumor below anal verge 3 cm
- T3 > 5 mm extramural spread
- T4 (involving surrounding structures or peritoneum)
- cN2 (4 or more mixed signal intensity or irregularly bordered node or tumor deposit)
- age 20 years or more
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- No prior chemotherapy, radiotherapy to pelvis
- Adequate bone marrow function
- Adequate renal function
- Adequate hepatic function
- patients must sign the informed consent indicating that they were aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion Criteria:
- malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
- any unresected synchronous colon cancer
- any distant metastases
- intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
- any previous or concurrent malignancy withih 5 years other than non-melanoma skin cancer / in situ cancer of uterine cervix / early gastric cancer / thyroid cancer of low risk
- any other morbidity or situation with relative contraindication for chemoradiotherapy
- patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine
- pregnant or lactating women or patients of childbearing potential not predicting adequate contraception
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：chemoradiation followed by CapOx
preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by 2 cycles of chemotherapy (Capecitabine Oxaliplatin - CapOx) and surgery (total mesorectal excision)
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after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks.
其他名称：
50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil
其他名称：
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有源比较器：chemoradiation
preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by rest for 8 weeks and surgery (total mesorectal excision)
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50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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downstaging rate
大体时间：expected average of 15 weeks after start of study treatment
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downstaging rate is defined as the proportion of patients with ypStage (pathologic stage after preoperative treatment) 0 or I (from pathologic findings after preoperative treatment and surgery) out of all patients who were assigned to each arm.
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expected average of 15 weeks after start of study treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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pathologic response
大体时间：expected average of 15 weeks after start of study treatment
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pathologic response is assessed by Dworak's grading system from postoperative specimen.
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expected average of 15 weeks after start of study treatment
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radiologic response rate
大体时间：expected average of 14 weeks after start of study treatment
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radiologic response will be assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline 1.1
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expected average of 14 weeks after start of study treatment
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toxicity profile
大体时间：expected average of 35 weeks after start of study treatment
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Toxicities or any adverse events during study treatment, surgery and follow-up period will be assessed according to NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.0
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expected average of 35 weeks after start of study treatment
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pattern of failure
大体时间：3 years after surgery
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if any recurrent lesion is noticed, anatomic sites of recurrent lesions and the date and the name of exam or imaging study (physical exam, CT or MRI…) will be recorded in case report form.
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3 years after surgery
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local control rate
大体时间：3 years after surgery
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Local recurrence is defined as tumor recurrence confined in radiation field (pelvic cavity).
Cumulative incidence of local recurrence will be suggested.
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3 years after surgery
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relapse-free survival
大体时间：3 years after surgery
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Time from date of operation to date of recurrence of disease or deaths due to recurrence or progression of disease.
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3 years after surgery
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Disease-free survival
大体时间：3 years after surgery
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time from date of operation to date of recurrence of disease, a new occurrence of secondary colorectal cancer, a new occurrence of other malignancy, or deaths from any cause.
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3 years after surgery
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overall survival
大体时间：3 years after surgery
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time from date of operation to date of death due to any cause.
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3 years after surgery
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quality of life
大体时间：before study treatment, 7 weeks after completion of chemoradiation, and at 4 weeks after surgery
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quality of life will be measured with FACT-C
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before study treatment, 7 weeks after completion of chemoradiation, and at 4 weeks after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Sun Young Kim, MD、Asan Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年6月1日
初级完成 (实际的)
2017年9月1日
研究完成 (预期的)
2019年12月1日
研究注册日期
首次提交
2013年9月11日
首先提交符合 QC 标准的
2013年9月25日
首次发布 (估计)
2013年9月30日
研究记录更新
最后更新发布 (实际的)
2017年9月13日
上次提交的符合 QC 标准的更新
2017年9月12日
最后验证
2017年9月1日
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.
Capecitabine Oxaliplatin的临床试验
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AstraZenecaSWOG Clinical Trials Partnerships; Daiichi Sankyo招聘中乳腺癌美国, 中国, 丹麦, 英国, 大韩民国, 加拿大, 德国, 意大利, 比利时, 西班牙, 日本, 法国, 台湾, 希腊, 巴西, 瑞典, 波多黎各
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AstraZenecaDaiichi Sankyo招聘中乳腺癌西班牙, 中国, 美国, 意大利, 英国, 大韩民国, 比利时, 法国, 德国, 波兰, 日本, 越南, 加拿大, 巴西, 印度, 马来西亚, 台湾, 泰国, 澳大利亚, 奥地利, 火鸡, 香港, 保加利亚, 瑞士, 匈牙利, 新加坡
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Hospices Civils de Lyon未知