A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 32
- 主要终点
- Local recurrence
研究概览
简要总结
This is a multi-centre randomised trial comparing long course (LC) preoperative chemoradiation with short course (SC) preoperative radiotherapy for patients with localised T3 rectal cancer.
详细描述
Objective:
- The objective is, in patients with T3 clinically resectable carcinoma of the rectum, to demonstrate that the local recurrence rate in patients treated with a long course (LC) of pre-operative radiotherapy with continuous infusion 5-FU is lower than that in patients treated with a short course (SC) of pre-operative radiotherapy with early surgery
Eligibility Criteria:
- The main eligibility criteria are that the patient has clinically resectable adenocarcinoma of the rectum, a clinical stage T3 tumour whose lower border is within 12 cm of the anal verge, and no evidence of distant metastases.
Endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •All of the following must apply:
- •Pathologically documented and clinically resectable adenocarcinoma of the rectum.
- •The patient must be considered by the surgeon to be suitable for a curative resection.
- •The patient must be considered by the radiation oncologist to have no contraindication to pre-operative radiotherapy.
- •Clinical T3 stage tumour on endorectal ultrasound or MRI. When endorectal ultrasound cannot be performed satisfactorily due to a technical reason, such as stenosis or proximity of the tumour, and MRI is not available, infiltration of perirectal fat on CT scan is also acceptable.
- •Tumour with lower border within 12 cm from anal verge on rigid sigmoidoscopy.
- •ECOG performance status 0, 1 or
- •Adequate bone marrow function with neutrophil count at least 1.5 x 109/L and platelet count at least 100 x 109/L.
- •Adequate liver function with bilirubin and alanine aminotransferase (ALT) <= 1.5 times the upper limit of normal.
- •Adequate renal function with serum creatinine <= 1.5 times the upper limit of normal.
- •Accessibility for treatment and follow-up.
- •Written informed consent.
排除标准
- •None of the following must apply:
- •Evidence of distant metastases.
- •Recurrent rectal cancer.
- •Unstable cardiac disease or clinically significant active infection.
- •Other cancer in the last 5 years except treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- •Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures.
- •Contraindication to insertion of a suitable indwelling venous catheter e.g. implantable central venous device (infuse-a-port), Hickman catheter or peripherally inserted central catheter.
- •Prior pelvic or abdominal radiotherapy.
研究组 & 干预措施
Short Course Radiotherapy
Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy
干预措施: Short Course Adjuvent Chemotherapy (Drug)
Short Course Radiotherapy
Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy
干预措施: Short Course Radiotherapy (Radiation)
Long Course Radiotherapy
Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
干预措施: Long Course Adjuvant Chemotherapy (Drug)
Long Course Radiotherapy
Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
干预措施: Long Course Radiotherapy (Radiation)
Long Course Radiotherapy
Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
干预措施: Concurrent Chemotherapy (Drug)
Surgery
Patients will receive initial surgery followed by post-operative management according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Adjuvant therapy for rectal cancer.
干预措施: Initial Surgery (Procedure)
结局指标
主要结局
Local recurrence
时间窗: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
次要结局
- Survival(Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial))
- Toxicity(Interim analyses will occur annually.)
- Abdominoperineal resection rate. This is defined as the proportion of all patients in any arm who undergo operation by abdominalperineal resection.(Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial))
- Quality of life(Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial))