NCT00220051已完成2 期
A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 主要终点
- Pathological complete response rate.
研究概览
简要总结
To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the treatment of patients with locally advanced or inoperable rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of adenocarcinoma of rectum.
- •Locally advanced/ poor prognosis primary rectal cancer defined by MRI criteria of any of the categories below;
- •Tumour within 2 mm of mesorectal fascia ie circumferential resection margin threatened
- •Any T3 tumour at/below levatores
- •T3c tumour at any other level ie tumour extends >5 mm into peri-rectal fat
- •T4 tumour
- •Any T stage with 4 or more involved lymph nodes
- •WHO performance status 0, 1 or
- •No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required.
- •Adequate bone marrow function with platelets > 100 X 109/l; WBC > 3 X 109/l; neutrophils > 1.5 X 109/l
- •Normal renal function, with serum creatinine within the normal range or calculated creatinine clearance >50 ml/min.
- •Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal range.
- •No concurrent uncontrolled medical conditions
- •No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
- •Adequate contraceptive precautions if relevant
- •Informed written consent
排除标准
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- •Presence of metastatic disease or recurrent rectal tumour
- •Renal impairment (creatinine clearance<30 ml/min)
- •Pregnancy or breast feeding
- •Patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes
- •Participation in any investigational drug study within the previous 4 weeks.
- •Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months)
- •Patients with any symptoms or history of peripheral neuropathy.
- •Prior pelvic radiotherapy
结局指标
主要结局
Pathological complete response rate.
Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent.
次要结局
- Progression-free survival
- Treatment related toxicity
- Overall survival
- Radiological response rate
- Proportion of patients achieving pathological down staging compared with the pre-treatment MRI scan
- Surgical complications
- Bowel function and quality of life
研究者
相似试验
尚未招募
1 期
XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric AdenocarcinomaGastric CarcinomaNCT03599778Anhui Provincial Hospital52
已完成
2 期
Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal CancerColorectal CancerNCT00220116Royal Marsden NHS Foundation Trust172
终止
2 期
Title XELOX FOR SALIVARY GLAND CANCERSHead and Neck CancerNCT00101075Dana-Farber Cancer Institute9
已完成
不适用
Phase II study of Capecitabine + oxaliplatin(CapeOx) for elderly patients with untreated metastatic gastric cancer <TCOG GI-1601>ntreated metastatic gastric cancerJPRN-UMIN000022450The Tokyo Cooperative Oncology Group110
已完成
2 期
Perioperative capecitabine plus oxaliplatin therapy for clinical stage III gastric cancerC16.9Gastric CancerJPRN-jRCTs051180109GOTO Masahiro37