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
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
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary soft tissue sarcoma
- •Sarcoma must be of the extremity or limb girdle origin
- •No metastatic disease
- •High-grade
- •Must be a candidate for preoperative irradiation for potential limb-sparing surgery
- •Must not have any of the following:
- •Embryonal rhabdomyosarcoma
- •Extraosseous Ewing sarcomas
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •ECOG performance status 0 - 2
- •WBC ≥ 3,500/μL OR granulocyte count ≥1,500/μL
- •Platelets ≥150,000/μL
- •Direct-reacting bilirubin ≤ 0.3 mg/dL
- •Creatinine ≤1.2 times the upper limit of normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
排除标准
- •Significant infection
- •Active heart disease including any of the following:
- •Myocardial infarction in the past 3 months
- •Symptomatic coronary artery insufficiency
- •First-degree heart block
- •Clinical history of congestive heart failure
- •Symptomatic pulmonary disease.
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or radiotherapy for cancer
结局指标
主要结局
Pulmonary metastatic progression-free rate at 2 years
次要结局
- Survival
- Time to progression
- Toxicity as per NCI CTC Version 2.0
- Tumor response every 4 weeks during treatment