NCT00422864已完成2 期
A Single-Arm Prospective Trial Evaluating The Local And Systemic Benefits Of Oxaliplatin And 5FU With Concurrent Radiation In Patients With Metastatic Rectal Cancer
Peter MacCallum Cancer Centre, Australia2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Tolerability rate
研究概览
简要总结
This trial is a single-arm study for patients presenting with both local and metastatic adenocarcinoma of rectum. The aims of the trial are (1) to determine the tolerability rate, and (2) to determine toxicity rates, pelvic and distant response rates in patients with locally advanced rectal cancer in the presence of distant metastasis who are treated with an interdigitating chemotherapy (oxaliplatin/5-fluorouracil [5FU]) and radiotherapy regimen.
详细描述
- Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs, then 5-FU 400mg/m2 bolus Day 1, then 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1.
- Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy,
- Week 6: as per Week 1,
- Weeks 8-10: as per Weeks 3-5
- Weeks 11: as per Week 1.
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
- •Patients with previously untreated and pathologically proven adenocarcinoma of the rectum with distant metastasis who would benefit from combined local therapy and systemic chemotherapy.
- •Lower border of tumour must be within 15cm of anal verge.
- •Age >= 18 years.
- •ECOG Performance Status 0-2
- •Absolute Neutrophil Count > 1.5x10^9/L, haemoglobin > 100 g/L, and platelets > 100x10^9/L.
- •Renal: Creatinine clearance >= 55 mL/min (using radioisotope renal scan or derived from serum creatinine using the Cockcroft-Gault formula).
- •Bilirubin <= 2.0 x upper limit of normal.
- •ALT <= 5 x upper limit of normal
- •Life expectancy in excess of 3 months.
- •No symptomatic peripheral neuropathy > grade
- •Males or non-pregnant, non-lactating females. Female patients of child-bearing potential, not surgically sterilized, must use an adequate form of contraception (oral contraceptive pill or barrier method).
- •Signed informed consent
排除标准
- •Prior pelvic radiotherapy
- •Febrile intercurrent illness or infection.
- •History of myocardial infarction within the previous six months or unstable cardiac disease or any other medical condition likely to compromise the safe delivery of chemotherapy or radiotherapy.
- •Concurrent treatment with other anti-cancer therapy.
- •Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
- •Locally recurrent rectal cancer
结局指标
主要结局
Tolerability rate
时间窗: as per protocol
次要结局
- Distant response rate(as per protocol)
- Pelvic response rate(as per protocol)
- Toxicity rates(as per protocol)
研究者
研究点 (2)
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