A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 主要终点
- Pathological Response
研究概览
简要总结
The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome
详细描述
This is a phase II , open label, randomized study in patients with confirmed diagnosis of locally advanced rectal cancer. The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Consent to this study
- •Histological or cytological confirmed diagnostic of rectal carcinoma
- •Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI)
- •4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction
- •5.With no presence of other organ metastasis or extra-regional lymph node involvement
- •6.With no history of chemotherapy
- •7.ECOG score is 0 or 1
- •8.Adequate ability of bone marrow, liver and kidney function
- •9.No pregnancy
排除标准
- •Unable to intake oral medicine
- •Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ；Congestive Heart Failure NYHA II grade or severe
- •HIV infection or Active chronic HBV or HCV
- •Severe clinical infection at active stage
- •Epileptic seizure need treatment
- •History of organ transplantation
- •Renal failure or intaking renal dialysis
- •Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics
- •Severe unhealed wound or skin ulcer or bone fraction
- •Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years
- •12.Chronic inflammatory bowel disease， bowel obstruction，hereditary fructose intolerance 13.Medicine abuse；medical，psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy
研究组 & 干预措施
Preoperative chemotherapy with short-course radiotherapy
Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
干预措施: Short-course radiotherapy (Radiation)
Preoperative chemotherapy with short-course radiotherapy
Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
干预措施: FOLFOX4 chemotherapy,preoperative (Drug)
Preoperative chemotherapy with short-course radiotherapy
Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
干预措施: Radical rectal cancer resection (Procedure)
Preoperative chemotherapy with short-course radiotherapy
Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
干预措施: FOLFOX4 chemotherapy,post-operative (Drug)
Preoperative neo-adjuvant therapy
Preoperative treatment:neo-adjuvant therapy
干预措施: Radiotherapy of neo-adjuvant therapy (Radiation)
Preoperative neo-adjuvant therapy
Preoperative treatment:neo-adjuvant therapy
干预措施: Concurrent chemotherapy of neo-adjuvant therapy (Drug)
Preoperative neo-adjuvant therapy
Preoperative treatment:neo-adjuvant therapy
干预措施: Radical rectal cancer resection (Procedure)
Preoperative neo-adjuvant therapy
Preoperative treatment:neo-adjuvant therapy
干预措施: FOLFOX4 chemotherapy,post-operative (Drug)
结局指标
主要结局
Pathological Response
时间窗: Surgery
Treatment effects of interventions. The tumor response should be graded on a scale of 0 (complete response- no viable cancer cells observed) to 3 (poor response - minimal or no tumor kill; extensive residual cancer)
次要结局
- 3-year Disease-Free Survival(3 years)
- 3-year Overall Survival(3 year)
研究者
Long Cui
Chief Director of Colorectal Surgery
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine