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临床试验/NCT00112697
NCT00112697已完成2 期

Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

UNICANCER10 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2003年10月6日最近更新:
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
UNICANCER
入组人数
71
试验地点
10
主要终点
Progression-free survival rate at 6 months

研究概览

简要总结

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

详细描述

OBJECTIVES:

Primary

  • Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combination with either fluorouracil or cisplatin as first-line therapy.

Secondary

  • Compare the toxicity of these regimens in these patients.
  • Compare the objective response rate in patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm 1

Experimental

干预措施: docetaxel (Drug)

Arm 1

Experimental

干预措施: fluorouracil (Drug)

Arm 1

Experimental

干预措施: radiation therapy (Radiation)

Arm 2

Experimental

干预措施: cisplatin (Drug)

Arm 2

Experimental

干预措施: docetaxel (Drug)

Arm 2

Experimental

干预措施: radiation therapy (Radiation)

结局指标

主要结局

Progression-free survival rate at 6 months

次要结局

  • Toxicity
  • Objective response rate
  • Overall survival

研究者

发起方
UNICANCER
申办方类型
Other
责任方
Sponsor

研究点 (10)

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