Multi-center Study of Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in the Management of Locally Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 204
- 试验地点
- 3
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
Compared to postoperative chemotherapy combined with radiotherapy, preoperative chemotherapy combined with radiotherapy shows higher sphincter preservation rate and lower local recurrence rate in locally advanced rectal cancer. The purpose of this study is to evaluate the response and prognosis of intraarterial chemoembolization and intravenous infusion chemotherapy in patients with rectal T3-T4 and/or N+ rectal cancer before operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of rectal cancer, Stage IV.
- •Males or females between 18 Years to 75 Years.
- •No prior cisplatin-based chemotherapy or radiotherapy.
- •Performance status of 0～2 on the ECOG criteria.
- •Adequate hematologic (Leukocyte count >= 4,000/uL, neutrophil count >= 1,500/uL, hemoglobin >= 10 g/dL, platelets >= 100,000/uL), hepatic (AST & ALT =< upper normal limit(UNL)x1.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL x1.5 or creatinine clearance rate ≥60 ml/min) function.
- •Patient can take oral medicine
- •Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.
排除标准
- •Patient with allergic to S-1 or ingredient of Oxaliplatin
- •Patient with Peripheral neuropathy
- •Diagnosed fibrosis of lung;pulmonary fibrosis or interstitial pneumonia within 28 days.
- •Medically uncontrolled serious heart, renal failure, liver failure, hemorrhagic peptic ulcer, paralysis of intestine , ileus, poor controlled diabetes.
- •Enrollment in other study.
- •Pregnant or breast-feeding.
- •Seriously psyche or intelligence problem.
- •Inability to comply with protocol or study procedures.
研究组 & 干预措施
NATACE-RT
Patients receive Oxaliplatin 130mg/m2 intraarterial chemoembolization on day1, and then radiation ( 44 Gy/20 fractions/4 weeks, from day 7 to day 11, day14 to day 18, day 21 to day 25, day 28 to day 32) plus oral S-1 (BSA < 1.25 mm2 receive 80 mg/day; 1.25 mm2 < BSA < 1.5mm2 recive 100 mg/day, BSA>1.5mm2 receive120 mg/day, twice daily, from day 1 to day 28, every 4 weeks)
干预措施: intraarterial chemoembolization (Device)
NACT-RT
Patients receive Oxaliplatin 130mg/m2 intravenous chemotherapy on day1, and then radiation ( 44 Gy/20 fractions/4 weeks, from day 7 to day 11, day14 to day 18, day 21 to day 25, day 28 to day 32) plus oral S-1 (BSA < 1.25 mm2 receive 80 mg/day; 1.25 mm2 < BSA < 1.5mm2 recive 100 mg/day, BSA>1.5mm2 receive120 mg/day, twice daily, from day 1 to day 28, every 4 weeks)
干预措施: intravenous chemotherapy (Device)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: pathologic examination following surgery, at aproximately 9-10 weeks or after preoperative intraarterial chemoembolization plus radiotherpy
Pathological complete response (pCR) was determined on tumor resection specimens after completion of neoadjuvant therapy, and was defined as no evidence of residual invasive and ductal disease in the rectum and lymph nodes
次要结局
- Down Staging Rate(Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks))
- Disease-free survival(Following surgery, 5 years)
- Overall Survival(the first day of treatment to death or last survival confirm date; assesed up to 5 years)
- Number of Participants with Adverse Events(Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks))
- Number of Postoperative Complication(Until surgery at 8-9 weeks post chemoradiation plus radiation (which is 4-5 weeks))
- the Sphincter Preservation Rate(3 month)
研究者
Dong Wang
chief physician
Third Military Medical University