NEOadjuvant chemotherapy only compared with standard treatment for Locally Advanced Rectal cancer: a randomized phase II trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 6
- 主要终点
- Disease free survival
研究概览
简要总结
The aim of the present study is to compare long term and short term outcomes in rectal cancer patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental neoadjuvant chemotherapy/surgery
详细描述
The standard treatment of locally advanced but resectable cancer in the middle or lower rectum is preoperative radio-chemotherapy and in the upper part initial surgery. The clinical benefit from radio-chemotherapy is primarily through a reduction in local relapse but the treatment is associated with acute toxicity and long term functional dysfunction. Subsequently, it is important to select patients with high risk of local relapse. Intense systemic combination chemotherapy reduces the risk of distant relapse and increases survival in the postoperative setting. The biological rationale is eradication of micrometastases and hence it may be anticipated that earlier, i.e. neoadjuvant, combination therapy may improve systemic control.
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 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the rectum with the lower boarder within 15 cm from the anal verge. Locally advanced tumor based on imaging (Tumors within 10 cm from the anal verge fulfilling the criteria for preoperative radio-chemotherapy according to DCCG guidelines, T3c or T4 tumors 10-15 cm from the anal verge). Deemed resectable at the multidisciplinary team (MDT) conference. ECOG performance status 0-
- •Age at least 18 years. Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l., Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, Calculated or measured renal glomerular filtration rate at least 30 mL/min). Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner or hormonal contraceptive are acceptable. Written and orally informed consent
排除标准
- •Distant metastasis • Invasive ingrowth into other organs • Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy • Previous radiotherapy to the pelvis • Previous treatment with 5FU or oxaliplatin • Surgery within two weeks • Neuropathy NCI grade > 1 • Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri • Pregnant (positive pregnancy test) or breast feeding women
结局指标
主要结局
Disease free survival
Disease free survival
次要结局
- • Overall survival • Local and distant relapse • Early and late toxicity • Functional outcome and QoL • Resection rate • Postoperative morbidity • Postoperative mortality • Rate of downsizing • Tumor regression grade • Translational research
研究者
Ismail Gögenur
Scientific
Region Sjaelland