NCT00590278已完成2 期
A Phase-II Study Of TOMUDEX Plus Radiotherapy In Subject With Inoperable or Recurrent Rectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- This study will evaluate the value of TOMUDEX in combination with a 'standard' course of pelvic radiotherapy for inoperable/recurrent rectal cancer, in terms of response rate and increasing the resectability rate
研究概览
简要总结
The pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response rate and increasing the resectability of initially 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
- •Confirmed diagnosis of inoperable/recurrent rectal cancer
- •Age > 18 years
- •At least 1 measurable lesion should be present
- •WHO performance score < 2
- •Life expentancy of at least 12 weeks
- •Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
- •Documented informed consent to participate in the trial
排除标准
- •Previous systemic chemotherapy
- •Previous radiotherapy to the planned exposure area
- •Subjects with distant metastases
- •(a)white blood cell < 4.0x109/L (unless absolute neutrophil count is >2.0x109/L or (b) Platelet count < 100x109/L
- •Serum creatinine above the upper limit of the normal range
- •(a) Serum bilirubin > 1.25 times the upper limit of the normal range or (b) Asparate aminotransferase(AST) or Alanine amiontransferase (ALT) >2.5 times the upper limit of the normal range
- •Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial period
- •Pregnancy or breast feeding. Women of childbearing age must use effective contraception
- •Previous or current malignancies at other sites, with the exception of adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
- •Patient participation in other studies
结局指标
主要结局
This study will evaluate the value of TOMUDEX in combination with a 'standard' course of pelvic radiotherapy for inoperable/recurrent rectal cancer, in terms of response rate and increasing the resectability rate
次要结局
未报告次要终点
研究者
研究点 (2)
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