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临床试验/NCT00652860
NCT00652860已完成2 期

Chemotherapy, Irradiation, and Surgery for Function-Preserving Curative Therapy of Primary Extremity Soft Tissue Sarcomas: Initial Treatment With I-MAP and GM-CSF; Aerosol GM-CSF During Preoperative Irradiation and Postoperatively

Mayo Clinic0 个研究点目标入组 39 人开始时间: 2001年8月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Mayo Clinic
入组人数
39
主要终点
Pulmonary metastatic progression-free rate at 2 years

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing. GM-CSF, given by inhalation, may interfere with the growth of tumor cells and prevent metastases from forming. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy and GM-CSF before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and GM-CSF before and after surgery works in treating patients with stage III soft tissue sarcoma that can be removed by surgery.

详细描述

OBJECTIVES:

Primary

  • To evaluate 2-year pulmonary metastatic progression rates in patients with primary high-grade extremity soft tissue sarcoma who have received preoperative I-MAP, plus aerosol GM-CSF, plus irradiation with concomitant MAP followed by post-operative aerosol GM-CSF.

Secondary

  • To evaluate survival of these patients.
  • To evaluate time to progression in these patients.
  • To evaluate toxicity in these patients.
  • To evaluate tumor response in these patients.

研究设计

研究类型
Interventional
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Pulmonary metastatic progression-free rate at 2 years

次要结局

  • Tumor response every 4 weeks during treatment
  • Survival
  • Time to progression
  • Toxicity as per NCI CTC Version 2.0

研究者

发起方
Mayo Clinic
申办方类型
Other

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