NCT00003052已完成3 期
Randomized Study Comparing Neoadjuvant Chemotherapy Etoposide + Ifosfamide + Adriamycin (EIA) Combined With Regional Hyperthermia (RHT) Versus Neoadjuvant Chemotherapy Alone in the Treatment of High-Risk Soft Tissue Sarcomas in Adults
European Organisation for Research and Treatment of Cancer - EORTC4 个研究点 分布在 1 个国家目标入组 340 人开始时间: 1997年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 4
- 主要终点
- Local progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not known whether receiving chemotherapy plus hyperthermia is more effective than receiving chemotherapy alone in treating patients with soft tissue sarcoma.
PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and hyperthermia therapy in treating patients with soft tissue sarcoma.
详细描述
OBJECTIVES:
- Determine local progression-free survival of patients with high-risk soft tissue sarcoma treated with neoadjuvant etoposide, ifosfamide, and doxorubicin with or without regional hyperthermia.
- Determine the tumor response rate, local disease control rate, and overall survival in patients treated with this regimen.
OUTLINE: This is a randomized study. Patients are stratified according to high-risk category (S1 vs S2 vs S3) and disease site (extremity vs nonextremity). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive etoposide IV over 30 minutes on days 1 and 4, ifosfamide IV over 60 minutes on days 1-4, and doxorubicin IV over 30 minutes on day 1. Treatment continues every 21 days for a total of 4 courses. Patients also undergo regional hyperthermia.
- Arm II: Patients receive chemotherapy alone as in arm I. Patients in both arms undergo definitive surgery 4-6 weeks after chemotherapy. Patients also undergo radiotherapy beginning 4-6 weeks after surgery. After completion of surgery and radiotherapy, patients with non-resectable tumors showing no disease progression receive an additional 4 courses of chemotherapy with or without regional hyperthermia according to above treatment schedule.
Patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven grade II or III soft tissue sarcoma of one of following high-risk groups:
- •Grade II/III primary tumor with lesion size of at least 5 cm, deep, and extracompartmental (S1)
- •Local recurrence of primary tumor (S2)
- •Inadequate surgical excision of S1 or S2 (S3)
- •Disease recurrence after prior surgery allowed
- •The following histological types are eligible:
- •Malignant fibrous histiocytoma
- •Liposarcoma (round cell and pleomorphic)
- •Leiomyosarcoma
- •Fibrosarcoma
- •Rhabdomyosarcoma
- •Synovial sarcoma
- •Malignant paraganglioma
- •Neurofibrosarcoma (malignant schwannoma)
- •Extraskeletal Ewing's sarcoma
- •Extraskeletal osteosarcoma
- •Malignant peripheral neuroectodermal tumors
- •Mesenchymal chondrosarcoma
- •Angiosarcoma
- •Miscellaneous sarcoma
- •Unclassified sarcoma
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •WHO 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No bleeding disorder
- •Bilirubin less than 1.25 times upper limit of normal
- •No severe hepatic dysfunction
- •Creatinine clearance greater than 60 mL/min
- •No chronic renal failure
- •Cardiovascular:
- •No documented existing cardiac failure
- •No manifest heart failure (New York Heart Association class III or IV)
- •Left ventricular ejection fraction no more than 10% below institutional normal
- •No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- •No other severe disease
- •No severe cerebrovascular disease
- •No extremely obese patients
- •No prior metallic implants relevant to the regional hyperthermia field
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- 另有 8 项未显示
排除标准
- 未提供
结局指标
主要结局
Local progression-free survival
次要结局
- Response as assessed by WHO criteria
- Overall survival
- Relapse-free survival
- Acute and late complications as assessed by CTC v 1.0
研究者
研究点 (4)
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