A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 67
- 主要终点
- 3-Year Disease-free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients who are undergoing surgery for stage I rectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the 3-year disease-free survival rate in patients with stage I adenocarcinoma of the rectum treated with neoadjuvant chemoradiotherapy comprising capecitabine, oxaliplatin, and radiotherapy followed by local excision.
Secondary
- Determine the rate of resectability with negative resection margins in patients treated with this regimen.
- Determine the procedure-specific morbidity and mortality in patients treated with this regimen.
- Determine the rate of pathologic complete response of the primary tumor in patients treated with this regimen.
- Determine the impact of this regimen on anorectal function and quality of life in these patients.
- Determine the feasibility of using molecular studies to assess surgical resection margins and tumor response in patients treated with this regimen.
- Determine molecular markers associated with local tumor recurrence in patients treated with this regimen.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment (capecitabine, oxaliplatin, radiotherapy, surgery)
Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29.
Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
干预措施: capecitabine (Drug)
Treatment (capecitabine, oxaliplatin, radiotherapy, surgery)
Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29.
Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
干预措施: oxaliplatin (Drug)
Treatment (capecitabine, oxaliplatin, radiotherapy, surgery)
Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29.
Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
干预措施: neoadjuvant therapy (Procedure)
Treatment (capecitabine, oxaliplatin, radiotherapy, surgery)
Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29.
Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
3-Year Disease-free Survival
时间窗: Up to 3 years
The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival.
次要结局
- R0 Resection Rate (Negative Margin Rate)(At time of surgery)
- Morbidity and Mortality Rate(Up to 30 days)
- Rate of Pathologic Complete Response of the Primary Tumor(Up to 5 years)
- Local Recurrence Rate(Up to 5 years)