Safety and Efficacy of Induction and Individualized Neoadjuvant Chemotherapy Based on Oxaliplatin Combined With Fluorouracil for MRF-negative, Moderate-risk and Initially Resectable Middle and Low Rectal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- pathologic complete response rate
研究概览
简要总结
This study is designed to test the Safety and efficacy of induction and individualized neoadjuvant chemotherapy based on oxaliplatin combined with fluorouracil for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.
详细描述
Preoperative chemoradiation has become standard treatment for stage 2/3 rectal cancer. But for moderate-risk rectal cancer patients, whether neoadjuvant chemotherapy followed with total mesorectal excision is adequate for local control is still unknown. The necessity of preoperative radiotherapy for these patients needs further exploration.
This study is a single-arm, single-center, prospective, phase II clinical study. It is designed to test the efficacy and safety of neoadjuvant chemotherapy for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.
In this study, patients with MRI defined moderate-risk rectal cancer will receive a three-month neoadjuvant chemotherapy based on Oxaliplatin combined with Fluorouracil(CapeOX,SOX,mFOLFOX6,etc.) and Total mesorectal excision.
Primary Endpoint is pCR rate.Secondary endpoint concludes toxic reactions of neoadjuvant chemotherapy, Incidence of surgical complications and three-year disease-free survival (DFS).
This study is designed to recruit 119 patients in all.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age ≥18 years and ≤80 years
- •ECOG Performance status 0-1
- •Histologically confirmed diagnosis of adenocarcinoma of the rectum
- •The distance from down verge of tumor to anal-rectal junction (ARJ) ≤8cm based on MRI, or ≤12cm based on sigmoidoscopy;
- •Clinical Stage based on MRI
- •T3c/T3d/T4a, anyN, or T3bN+
- •No evidence of distant metastases
- •No prior pelvic radiation therapy
- •No prior chemotherapy or surgery for rectal cancer
- •No active infections requiring systemic antibiotic treatment
- •ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.
- •Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
排除标准
- •• Recurrent rectal cancer
- •Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins.
- •The pathological grade was Grade 4, i.e. mucus, signet ring or undifferentiated cancer.
- •Creatinine level greater than 1.5 times the upper limit of normal.
- •Patients who have received prior pelvic radiotherapy.
- •Patients who are unable to undergo an MRI.
- •Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
- •Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
- •Other Anticancer or Experimental Therapy.
- •Women who are pregnant or breast-feeding.
- •Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
研究组 & 干预措施
Neoadjuvant chemotherapy
Oxaliplatin 130mg/m2 d1 and Capecitabine 1250mg/m2 bid1-14 or other fluorouracils, every 21 or 14 days for 2 to 4 cycles, and efficacy evaluation every 2 cycles;
干预措施: Oxaliplatin and capecitabine (Drug)
Neoadjuvant chemotherapy
Oxaliplatin 130mg/m2 d1 and Capecitabine 1250mg/m2 bid1-14 or other fluorouracils, every 21 or 14 days for 2 to 4 cycles, and efficacy evaluation every 2 cycles;
干预措施: Total Mesorectal Excision (Procedure)
结局指标
主要结局
pathologic complete response rate
时间窗: 30 days
the number of patients with pCR divided by the total number of patients
次要结局
- surgical complication rate(30 days after the operation)
- Toxicity of neoadjuvant chemotherapy(4 months)
- 3 year disease-free survival(three years after the enrollment)
研究者
Aiwen Wu
chief, Unit III & Ostomy Service, Gastrointestinal Cancer
Peking University Cancer Hospital & Institute