NCT01129700已完成2 期
Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- To evaluate the pathologic response
研究概览
简要总结
Concurrent chemoradiotherapy (CRT)
-
Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1)
-
↓ ↓ ↓ ↓ ↓
-
Radical surgery 6 weeks after completion of chemoradiotherapy
-
↑ ↑ ↑ ↑ ↑ D1 - - - - - D5
-
5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy
详细描述
Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in 5 fractions.
A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered concurrently on day 1-5 during radiotherapy.
Total mesorectal excision is performed within 6±2 weeks. The pathological response of downstaing is the study endpoint.
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
- •Pathologically proven diagnosis of adenocarcinoma of the rectum (located within 8㎝ above the anal verge)
- •Locally advanced and curatively resectable tumor(cT3-4 classification) evaluated with magnetic resonance imaging(MRI) with or without transrectal ultrasonography(TRUS)
- •Performance Status(ECOG) 0-2
- •CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Hemoglobin ≥ 10 g/dl, Absolute neutrophil count(ANC) ≥ 1,500 cells/㎣, Platelets ≥ 100,000cells/㎣
- •Metabolic panel within 14 days prior to registration on study, with adequate liver and renal function defined as follows: AST and ALT ≤ 60 IU/L, bilirubin ≤ 1.5 mg/dl, serum creatinine ≤ 1.5 mg/dl
- •Patient must provide study-specific informed consent prior to study entry
排除标准
- •Any evidence of distant metastases(M1)
- •Prior invasive malignancy (except non-melanomatous skin cancer and uterine cervical cancer in situ) unless disease free to a minimum of 3 years
- •Hereditary rectal cancer; Familial adenomatous polyposis(FAP), Hereditary non-polyposis colorectal cancer(HNPCC), etc.
- •Impending obstruction (except the case with colostomy)
- •Severe, active comorbidity inappropriate to CRT as follows; Acute bacterial or fungal infection, transmural myocardial infarction within the last 6 months, unstable arrhythmia, angina and/or congestive heart failure, unstable arrhythmia
- •Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- •Unresected synchronous colon carcinoma
- •Clinically unresectable rectal cancer
研究组 & 干预措施
short-course CRT-5FU
Experimental
干预措施: Radiation: short-course preoperative chemoradiotherapy (Radiation)
结局指标
主要结局
To evaluate the pathologic response
时间窗: After surgery with pathology data
downstaging(ypT0-2N0M0)rate
次要结局
- Tumor regression grade & MR volumetry(After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery)
- Acute/ late toxicities(preoperative CCRT to 3 months after surgery)
研究者
DAE YONG KIM
Principal Investigator
National Cancer Center, Korea
研究点 (1)
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