Total Neoadjuvant Therapy With Additional Consolidation Chemotherapy Followed by Local Excision Versus Total Neoadjuvant Therapy Followed by Local Excision at Stage I Rectal Cancer (OPTION)
Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial
Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial
The goal of this clinical trial is to find out if adding consolidation chemotherapy with capecitabine after total neoadjuvant chemoradiotherapy (TNT) works to improve oncologic outcomes in patients with stage I rectal cancer. It will also comparethe safety of adding consolidation chemotherapy before local excision.
The main questions it aims to answer are:
- Does adding consolidation chemotherapy increase the rate of pathologic complete response?
- What medical problems or side effects do participants have during and after treatment?
Researchers will compare TNT followed by local excision to TNT followed by consolidation chemotherapy with capecitabine and then local excision to see if adding consolidation chemotherapy improves tumor response and treatment outcomes.
Participants will:
- Receive TNT for stage I rectal cancer
- Be randomly assigned to one of two treatment groups
- Undergo local excision after preoperative treatment
- Visit the clinic for checkups and tests to evaluate tumor response, side effects, recurrence, survival, quality of life, bowel function, urinary function, sexual function, circulating tumor DNA, and treatment-related costs
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Seung-Bum Ryoo
- 电话号码：+82-010-3811-2516
- 邮箱：sbryoomd@gmail.com
学习地点
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Jongro-gu
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Seoul、Jongro-gu、韩国、03080
- Seoul National University Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Histologically confirmed rectall adenocarcinoma
- Low rectal cancer (AV < 15cm)
- cT2N0 disease, or pathologic stage T1N0 disease after endoscopic resection with at least one high-risk feature, including: Positive resection margin Lymphovascular invasion Tumor budding ≥5
- Ability to understand and comply with the requirements of the clinical trial
Exclusion Criteria:
- Patients who prefer radical rectal resection
- Prior history of surgery for rectal cancer
- Recurrent rectal cancer
- Synchronous metastatic rectal cancer
- Evidence of lymph node metastasis or distant metastasis on abdominopelvic CT or chest CT, including para-aortic, common iliac, or external iliac lymph node metastasis
- Uncontrolled active infection or other uncontrolled medical condition
- Known hypersensitivity to chemotherapy
- Patients considered unsuitable for participation in the clinical trial by the principal investigator or study personnel
学习计划
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：TNT with consolidation therapy
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5-FU based CCRT: 5 weeks Rest period: 1 week 5-FU (Capecitabine) Consolidation chemotherapy 3 cycles: 8 weeks Rest period: 1 week Local excision
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有源比较器：TNT without consolidation therapy
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5-FU based CCRT: 5 weeks Rest period: 10 weeks Local excision
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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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Pathologic complete response rate (ypT0)
大体时间：At pathologic assessment of the local excision specimen, approximately 10 weeks after completion of TNT
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Pathologic complete response of the primary tumor after neoadjuvant therapy
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At pathologic assessment of the local excision specimen, approximately 10 weeks after completion of TNT
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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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5-year Survival Rate
大体时间：5 years
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5-year Overall survival & 5-year Recurrence free survival
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5 years
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Low anterior resection syndrome (LARS)
大体时间：After local excision
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0-20, no / 21-29, minor / 30-42, major
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After local excision
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EORTC-QLQ, C30 score
大体时间：After local excision, 4weeks
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Quality of life surveillance
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After local excision, 4weeks
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Total medical costs
大体时间：5 years
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Total medical costs related to treatment, including chemoradiotherapy, chemotherapy, local excision, follow-up examinations, management of treatment-related complications, and additional treatment for recurrence, if applicable.
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5 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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.