A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Complete Pathological Response Rate
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. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together With selenomethionine and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well selenomethionine works when given together with capecitabine, oxaliplatin, and radiation therapy in treating patients undergoing surgery for newly diagnosed stage II or stage III rectal cancer.
详细描述
OBJECTIVES:
Primary
- To determine the complete pathological response rate of the combination of capecitabine, oxaliplatin, selenomethionine, and radiotherapy in patients with stage II or III rectal adenocarcinoma.
- To determine the T-downstaging rate with this regimen in patients with stage II or III rectal adenocarcinoma.
Secondary
- To determine the safety of this regimen by assessing toxicity and dose intensity of the various components of this regimen.
- To determine the rate of local relapse.
- To determine the rate of distant relapse.
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 75 Years（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
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
干预措施: selenomethionine (Dietary Supplement)
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
干预措施: capecitabine (Drug)
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
干预措施: oxaliplatin (Drug)
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
干预措施: laboratory biomarker analysis (Other)
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
干预措施: pharmacological study (Other)
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
干预措施: adjuvant therapy (Procedure)
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
干预措施: neoadjuvant therapy (Procedure)
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
干预措施: therapeutic conventional surgery (Procedure)
Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Complete Pathological Response Rate
时间窗: After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.
Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy
时间窗: After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.
次要结局
- Dose Intensity(During treatment with capecitabine, oxaliplatin, selenomethionine.)
- Local Relapse Rate(For up to 5 years following surgery.)
- Distant Relapse Rate(For up to 5 years following surgery.)
- Safety and Tolerability as Assessed by NCI CTCAE Version 3.0(Adverse events were queried for and collected every cycle for the duration of treatment.)