Randomised Phase II Study of Pre-operative 3-D Conformal Radiotherapy (3-DCRT) Versus Intensity Modulated Radiotherapy (IMRT) for Locally Advanced Rectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 94
- 试验地点
- 4
- 主要终点
- Reduction in incidence of grade 2 or higher GI toxicity
研究概览
简要总结
The study aims to compare the incidence of acute grade 2 GI toxicity in the Control 3-D Conformal Radiotherapy compared to the Intensity Modulated Radiotherapy (IMRT) arm for locally advanced rectal cancer.
详细描述
Pre-operative radiotherapy (RT) or chemo-radiotherapy (CRT) is internationally accepted as standard practice in the management of locally advanced rectal cancer.
Multiple randomised trials have proved pre-operative CRT and RT, compared to surgery alone, reduce local recurrence, even prior to optimal surgery, and may improve survival for T3 circumferential resection margin (CRM) negative patients.
This study aims to determine if 3-DCRT or IMRT result in lower incidence of grade 2 GI toxicities.
Acute toxicities will be assessed weekly during radiotherapy, and at 2 and 4 week post treatment.
Late toxicities will be assessed at 3, 6, 9, 12, 18, 24 months post treatment, and annually to 10 years.
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
- •Patients undergoing pre-operative pelvic chemo-radiotherapy for histologically confirmed rectal adenocarcinoma, with the following staging: cT3N0-2, cT4N0-2, cT(any)N1-2, cT(any)N(any) CRM at-risk [AJCC version V]
- •Staging / imaging of pelvis with MRI, and CT Thorax/Abdomen
- •No evidence of metastatic disease
- •ECOG Performance Status 0 - 2
- •Age > or equal to 18 years
- •Provision of written informed consent in line with ICH-GCP guidelines
排除标准
- •Previous radiotherapy to the pelvic region
- •Patients in whom induction chemotherapy has been delivered prior to chemo- radiotherapy
- •History of inflammatory bowel disease
- •Previous hip replacement
- •Previous bowel surgery (excluding procedures/operations which would not result in small bowel adhesions - at the discretion of the Principal Investigator)
- •Patients with other syndromes/conditions associated with increased radiosensitivity
- •Any other co-existing malignancies within the past 5 years other than non- melanoma skin cancer
- •Pregnancy or lactation at the time of proposed randomisation
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study or if it is felt by the research / medical team that the patient may not be able to comply with the protocol
研究组 & 干预措施
Experimental Arm
50.4 Gy / 28# external beam pelvic radiotherapy delivered using IMRT
干预措施: IMRT (Radiation)
Control Arm
50.4 Gy / 28# external beam pelvic radiotherapy delivered using a 3-Dimensional (3-D) planned technique
结局指标
主要结局
Reduction in incidence of grade 2 or higher GI toxicity
时间窗: 10 years
To determine if there is a reduction in the incidence of grade 2 or higher acute GI toxicity in the IMRT arm, as compared to the Control / 3-D arm, graded by the NCI-CTCAE Version 4
次要结局
- Assess quality of life(10 years)
- Rate of disease free survival(10 years)
- Compare incidence of acute grade > 2 GU toxicity(10 years)
- Differences in the toxicity profile between the two types of neoadjuvant concomitant chemotherapy, graded by the NCI-CTCAE Version 4(10 years)
- Rate of loco-regional control(10 years)
- Evaluate incidence of late GI and GU toxicity(10 years)
- Estimate overall survival(10 years)