Efficacy and Safety of Neoadjuvant Chemo-chemoradio-chemo Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer: a Phase II Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Compared curative effect，safety and compliance between concurrent chemoradiotherapy and chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.
详细描述
The patients were divided into two arms according to the defined conditions (pathology rectal adenocarcinoma；distal distance of tumor from anal verge < 10cm；TNM staging T3-4N0-2；no distant metastasis；Karnofsky score≥70) in this prospective, single center, open, non randomized trail (arm A:concurrent chemoradiotherapy, arm B:sequential therapy). Regimens:Arm A:50Gy,2Gy/day per time, 5 days a week, for 5 weeks. +capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks. Arm B: XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1, capecitabine 1000 mg/m2 Bid day 1-14, repeat every 3 weeks ) → 50Gy,2Gy/day per time, 5 days a week, for 5 weeks.+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks. Evaluate pre chemotherapy, pre radiotherapy and pre surgery individually. Surgeries followed TME(total mesorectal excision) and PANP(pelvic autonomic nerve preservation) for patients in both arms. Take pathological evaluation of tumors. Take XELOX therapy till 6-8 cycles(pre and after surgery total). Follow up according the schedule.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathology rectal adenocarcinoma
- •Distal distance of tumor from anal verge < 10cm
- •TNM staging T3-4N0-2(MRI)
- •No distant metastasis
- •Karnofsky score≥70
- •Female patients need contraception during the test
- •Postmenopausal women for at least 12 months, expect pregnancy possibility
- •Patients did not receive chemotherapy, radiotherapy in any form before
- •No other severe related diseases (such as other tumor, severe cardiac and central nervous system diseases, etc.)
排除标准
- •Be treated by radiotherapy, chemotherapy or tumor biological therapy before
- •Received immunosuppressive therapy (including corticosteroids)
- •Participated in other clinical trial(s) in 1 month
- •With malignant tumor of colon
- •Peripheral neuropathy (WHO I level and above)
- •Neurological or psychiatric abnormalities affecting cognition , including central nervous system metastasis
- •Severe allergies or allergic history
- •Severe pulmonary or heart disease
- •Pregnant or lactation or refuse contraception during the test
- •Suffering other malignant tumors in past
研究组 & 干预措施
Concurrent chemoradiotherapy
Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy
干预措施: Capecitabine (Drug)
Sequential therapy
XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy
干预措施: XELOX (Drug)
结局指标
主要结局
Disease free survival
时间窗: 3-year
次要结局
- R0 resection rate(1 year)
- Pathologic complete response(1 year)
- Local recurrence rate(3 years)
- Safety: Number of Participants with Adverse Events(3 years)
研究者
Binbin Cui
Director of Abdominal Surgery Department
Harbin Medical University