A Phase II Trial Of Celecoxib (Celebrex) And Capecitabine (Xeloda) Combined With Pelvic Irradiation As Neoadjuvant Treatment Of Stage II or III Adenocarcinoma Of The Rectum
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 主要终点
- Proportion of successes
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may also make tumor cells more sensitive to chemotherapy and radiation therapy. Giving celecoxib with capecitabine and radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving neoadjuvant celecoxib together with capecitabine and pelvic irradiation works in treating patients with stage II or stage III adenocarcinoma (cancer) of the rectum.
详细描述
OBJECTIVES:
Primary
- Determine the pathological complete response rate in patients with stage II or III adenocarcinoma of the rectum treated with neoadjuvant celecoxib and capecitabine in combination with pelvic irradiation.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
- Determine the rectal function of patients treated with this regimen.
- Determine the time to recurrence or progression and survival time of patients treated with this regimen.
- Correlate cellular and molecular markers in pretreatment tumor samples with response 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
celecoxib + capecitabine + radiation + surgery
Neoadjuvant chemoradiotherapy: Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5. Patients undergo pelvic radiotherapy once daily on days 1-5. Courses repeat weekly for 5.5 weeks.
Surgery: Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy.
Adjuvant chemotherapy: Patients with a curative resection receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 4 courses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: capecitabine (Drug)
celecoxib + capecitabine + radiation + surgery
Neoadjuvant chemoradiotherapy: Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5. Patients undergo pelvic radiotherapy once daily on days 1-5. Courses repeat weekly for 5.5 weeks.
Surgery: Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy.
Adjuvant chemotherapy: Patients with a curative resection receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 4 courses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: celecoxib (Drug)
celecoxib + capecitabine + radiation + surgery
Neoadjuvant chemoradiotherapy: Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5. Patients undergo pelvic radiotherapy once daily on days 1-5. Courses repeat weekly for 5.5 weeks.
Surgery: Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy.
Adjuvant chemotherapy: Patients with a curative resection receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 4 courses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: radiation therapy (Radiation)
celecoxib + capecitabine + radiation + surgery
Neoadjuvant chemoradiotherapy: Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5. Patients undergo pelvic radiotherapy once daily on days 1-5. Courses repeat weekly for 5.5 weeks.
Surgery: Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy.
Adjuvant chemotherapy: Patients with a curative resection receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for up to 4 courses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: surgery (Procedure)
结局指标
主要结局
Proportion of successes
时间窗: Up to 5 years
次要结局
- Time to first progression(Up to 5 years)
- Survival(Up to 5 years)
- Survival time(Up to 5 years)
- Time to disease progression/recurrence(Up to 5 years)
- Bowel function as measured by the Patient Bowel Function (Uniscale) Questionnaire, the FACT Diarrhea Subscale and the Mayo Bowel Function Questionnaire(Up to 5 years)
- Time-to event analyses(Up to 5 years)
- Time to recurrence(Up to 5 years)