TCTR20180516003进行中（未招募）未知
Oral capecitabine is a good alternative choice of infusional 5-FU as a neoadjuvant chemotherapeutic agent in chemoradiotherapy for the treatment of locally advanced rectal cancer.
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1)Clinically diagnosed and histopathologically proved adenocarcinoma of rectum.
- •2)Distal margin of the tumor located within 12 cm from the anal verge on colonofiberscopy.
- •3)All patients will be diagnosed as locally advanced carcinoma of rectum , clinical TNM staging, stage II (T3-4N0) or stage III (T1-4N1-2) by transrectal ultrasonography and computerized tomography (CT) scanning or magnetic resonance imaging (MRI).
- •4)Age 18-70 years.
- •5)Eastern Cooperative Oncology Group (ECOG) performance status of 2 or below.
- •6)Patients without synchronous distant metastases.
- •7)Adequate bone marrow reserve
- •a. white blood cell count ≥4000/mm3
- •b. absolute neutrophil count ≥1500/mm3
- •c. platelet count ≥100,000/mm3
- •d. haemoglobin ≥10g/dL
- •8)Adequate renal function
- •a. serum creatinine level ≤ 1.5 mg/dl
- •b. creatinine clearance rate ≥ 50mg/min
- •9)Adequate liver function
- •a. liver transaminase levels ≤ 3 times the upper normal limit
- •b. serum bilirubin level ≤ 1.5mg/d
排除标准
- •1)Those who are not willing.
- •2)Patients with distant metastases.
- •3)Patients with other tumor types than adenocarcinoma.
- •4)Age below 18 years and above 70 years.
- •5)Patients with history of prior chemotherapy or radiotherapy.
- •6)Initial surgery (excluding diagnostic biopsy) of the primary site.
- •7)Patients with double primaries.
- •8)Pregnant or lactating woman.
- •9)Patient dropped out or lost to follow up before completion of study.
- •10)Serious concomitant medical illness including severe heart disease, uncontrolled diabetes mellitus, hypertension or renal diseases
- •11)Patient with uncontrolled infection.
- •12)Poor performance status (ECOG score >2).
- •13)Prisoners.
- •14)Family history of rectal cancer when it was diagnosed as hereditary nonpolyposis colorectal cancer.
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