NCT00263029已完成2 期
Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 18
- 主要终点
- Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate).
研究概览
简要总结
The purpose of this phase II trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status score 0-
- •Chemo-naïve patients.
- •Histologically/cytologically confirmed diagnosis of rectal adenocarcinoma (clinically stage mT3 or mT4), either considered (1)inoperable, or (2)locally advanced, where histologically confirmed curative resection is considered unlikely.
- •Evaluable measurable disease on imaging with MRI/CT to allow for response assessment.
- •Adequate haematological, renal and liver functions as follows:
- •ANC > 3000ml
- •Platelet count > 100,000 ml
- •Urea & Serum Creatinine < 1.5 X upper limit of normal value
- •Total serum bilirubin < 1.5 X upper limit of normal value
- •ALT & AST < 3 X upper limit of normal value
排除标准
- •Prior chemotherapy.
- •Documented allergy to oxaliplatin or capecitabine.
- •Prior radiotherapy to pelvis.
- •Previous or concurrent malignancies at other sites with the exception of basal or squamous cell carcinoma of the skin.
- •Pregnant or lactating females (with negative pregnancy test documentation in pre-menopausal female patients).
- •Currently participating into another clinical trial with any investigational drug in the previous 30 days.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: Oxaliplatin (Drug)
1
Experimental
干预措施: Capecitabine (Drug)
1
Experimental
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Response rate (both clinical and pathological) of the primary rectal cancer observed after the chemoradiotherapy. Histologically confirmed complete resection rate (R0 rate).
时间窗: 3-years disease- free-survival or 3-years overall survival
次要结局
- Adverse events collection(From the signature of the informed consent up to the end of the study)
研究者
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