Multicenter Dose-escalation Trial of Radiotherapy in Patients With Locally Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 525
- 试验地点
- 10
- 主要终点
- Pathologic complete response
研究概览
简要总结
The aim of this study is to evaluate the increase of radiation dose administered in patients diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity, using IMRT (concomitant boost technique).
详细描述
The hypothesis that arises is an improvement in the proportion of pathological complete responses, resulting therapeutic gain, as a result of a higher dose of radiation delivered to the tumor volume without incurring a higher gastrointestinal toxicity to the patient or surgical complications later, thanks to the use of intensity modulated radiotherapy (concomitant boost technique) that allows us to significantly reduce the administered dose organs at risk.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven diagnosis of adenocarcinoma of the rectum
- •Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum
- •Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least <11cm from the anal verge
- •Adequate liver/renal and haematological function.
- •Eastern Cooperative Oncology Group (ECOG) performance 0-2
- •Age ≥ 18 years
- •Full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
- •Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
- •Platelets ≥ 100,000 cells/mm3
- •Haemoglobin ≥ 8.0 g/dl
- •Serum creatinine within normal institutional limits
- •Bilirubin within normal institutional limits
- •AST and ALT < 2.5 x the IULN
- •Patient must sign study specific informed consent prior to study entry
排除标准
- •Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable.
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •Any evidence of distant metastases (M1)
- •A synchronous primary colon carcinoma
研究组 & 干预措施
Treatment with IMRT Dose Escalation
Dose Escalation Intensity Modulated Radiotherapy treatment
干预措施: Dose Escalation Intensity Modulated Radiotherapy treatment (Radiation)
Treatment with 3DCRT
3DCRT treatment (sequential boost)
干预措施: 3DCRT treatment (sequential boost) (Radiation)
结局指标
主要结局
Pathologic complete response
时间窗: Through study completion, an average of 2 years
Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring
Gastrointestinal toxicity
时间窗: Two years
Gastrointestinal adverse events as assessed by CTCAE v4.0
次要结局
- Tumor regression grade(Through study completion, an average of two years)
- Disease free survival(Three years)
- Overall survival(Five years)
- Acute Toxicity(Two years)
- Quality of Life during the treatment(Three years after the study completion)
研究者
Fernando Campos
Doctor
Grupo de Investigación Clínica en Oncología Radioterapia