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临床试验/NCT00002643
NCT00002643已完成2 期

INTENSIVE THERAPY WITH GROWTH FACTOR SUPPORT FOR PATIENTS WITH EWING'S TUMOR METASTATIC AT DIAGNOSIS: A PEDIATRIC ONCOLOGY GROUP PHASE II STUDY

National Cancer Institute (NCI)49 个研究点 分布在 5 个国家目标入组 130 人开始时间: 1995年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
130
试验地点
49

研究概览

简要总结

Phase II trial to study the effectiveness of combination chemotherapy in treating patients with newly diagnosed metastatic Ewing's sarcoma or primitive neuroectodermal tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

详细描述

OBJECTIVES:

I. Evaluate the response rate and duration of response of patients with newly diagnosed, metastatic Ewing's sarcoma or primitive neuroectodermal tumor treated with maximally intensified VAdrC (vincristine, doxorubicin, cyclophosphamide) alternating with IE (ifosfamide, etoposide).

II. Evaluate the response to new agents (first topotecan, then topotecan with cyclophosphamide) utilized in an upfront treatment window.

III. Assess the role of surgery with regard to local control of primary and metastatic sites and disease course.

IV. Evaluate whether individual variability in ifosfamide and cyclophosphamide metabolism correlates with toxicity and/or response.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 30 Years(Child, 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 I

Experimental

See detailed description.

干预措施: filgrastim (Biological)

Arm I

Experimental

See detailed description.

干预措施: amifostine trihydrate (Drug)

Arm I

Experimental

See detailed description.

干预措施: cyclophosphamide (Drug)

Arm I

Experimental

See detailed description.

干预措施: doxorubicin hydrochloride (Drug)

Arm I

Experimental

See detailed description.

干预措施: etoposide (Drug)

Arm I

Experimental

See detailed description.

干预措施: ifosfamide (Drug)

Arm I

Experimental

See detailed description.

干预措施: topotecan hydrochloride (Drug)

Arm I

Experimental

See detailed description.

干预措施: vincristine sulfate (Drug)

Arm I

Experimental

See detailed description.

干预措施: conventional surgery (Procedure)

Arm I

Experimental

See detailed description.

干预措施: low-LET cobalt-60 gamma ray therapy (Radiation)

Arm I

Experimental

See detailed description.

干预措施: low-LET electron therapy (Radiation)

Arm I

Experimental

See detailed description.

干预措施: low-LET photon therapy (Radiation)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (49)

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