Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- pathological complete response (pCR)
研究概览
简要总结
The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:
- Is total neoadjuvant treatment in this design safe & tolerable?
- Impact of this design on treatment related outcomes in terms of pathological and clinical responses.
详细描述
Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathological proof of rectal adenocarcinoma.
- •Tumors located within 15 cm and not less than 4 cm from anal verge.
- •Age: ≥ 18 years.
- •Locally advanced resectable rectal cancer (cT3/4 N0- Any T N+ve).
- •ECOG Performance Status: 0-2.
排除标准
- •Non-epithelial rectal malignancy such as sarcoma or lymphoma.
- •Unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen.
- •Recurrent rectal cancer.
- •Previous history of malignancy within the last 5 years.
- •Previous pelvic irradiation.
- •Psychiatric or addictive disorder that would preclude study therapy.
- •Concurrent uncontrolled medical conditions.
- •Pregnancy or breast feeding.
- •Any contraindication to surgery.
- •Extensive peripheral neuropathy.
研究组 & 干预措施
Short course RT followed by full course of chemotherapy then surgery
Short course radiation therapy ( 25 Gy/ 5 fractions/ 1 week) , followed by 6 cycles of chemotherapy CAPOX, followed 4-6 weeks by surgery.
干预措施: short course radiation therapy followed by 6 cycles of CAPOX then surgery (Radiation)
结局指标
主要结局
pathological complete response (pCR)
时间窗: within 30 days
No residual disease in surgical specimen
clinical complete response(cCR)
时间窗: within 30 days
No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy
Sphincter saving surgery
时间窗: within 6 months
Patients who were deemed abdomino-perineal resection before treatment start \& were able to undergo low anterior resection after end of treatment
次要结局
- Local control(3 years)
- Overall survival(3 years)
- Disease free survival(within 3 years)
研究者
Yasser Anwar
Lecturer of Radiation Oncology
National Cancer Institute, Egypt