NCT01271192Unknown不适用
A Randomized Multicenter Clinical Trial of Direct Surgical Resection Compared to Neoadjuvant Followed by Surgical Resection in Treating Patients With Operable Local Recurrent Carcinoma Of The Rectum
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- 5-year disease free survival
研究概览
简要总结
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown.
PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.
详细描述
OBJECTIVES:
Primary
- Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.
Secondary
- Compare the side effect of chemo radiotherapy according to the Common Toxicity Criteria(CTC) version 2.0 in patients treated with these regimens.
- Compare the postoperative complications in patients treated with these regimens.
- Compare the recurrent rate in patients treated with these regimens.
- Compare the distant metastatic rate in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Adenocarcinoma of the rectum
- •Age:18-80 years old
- •Received curative resection when diagnosed as rectal cancer
- •Local recurrence happened >6 months after operation,without distant metastasis
- •Local recurrent mass is resectable confirmed by surgeon and radiologist 6.15 days prior recruit, meet the following criteria:
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2 times ULN
- •AST ≤ 2.5 times ULN
- •ALT ≤ 2.5 times ULN
- •No hepatic disease that would preclude study treatment or follow-up
- •No uncontrolled coagulopathy
- •Creatinine clearance > 50 mL/min
- •No renal disease that would preclude study treatment or follow-up
- •7.ECOG status: 0～1
排除标准
- •Other rectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
- •Synchronous colon cancer
- •Hypersensitivity to fluorouracil
- •No More than 4 weeks since prior participation in any investigational drug study
- •Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
- •History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception
- •Uncontrolled hypertension
- •Cardiovascular disease that would preclude study treatment or follow-up
- •Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
- •Pregnant or nursing, Fertile patients do not use effective contraception
- •Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
- •No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
结局指标
主要结局
5-year disease free survival
时间窗: 5 years
Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.
次要结局
- Side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate,biomarkers, quality of life, toxic profile, convenience(5 years)
研究者
研究点 (1)
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