RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 45
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. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma.
详细描述
OBJECTIVES:
- Compare the local disease control, overall survival, and relapse-free survival in patients with high-grade soft tissue sarcoma treated with adjuvant high-dose doxorubicin and ifosfamide plus filgrastim (G-CSF) vs no adjuvant chemotherapy and G-CSF after definitive surgery.
- Compare the toxicity and morbidity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, site of primary tumor (extremity vs trunk, including shoulder, pelvic girdle, head, or neck vs central, including intrathoracic, visceral, uterine, or retroperitoneal), size of primary tumor (less than 5 cm vs 5 cm or greater in largest diameter), postoperative radiotherapy (yes vs no), and isolated limb perfusion therapy (yes vs no).
Some patients undergo isolated limb perfusion therapy with cytotoxics and/or cytokines.
No more than 8 weeks after biopsy or inadequate surgery, patients undergo definitive surgery. Patients with complete resection undergo radiotherapy assessment and then randomization. Patients with incomplete or marginal resection (except for central lesions) undergo re-excision and, in the absence of macroscopic disease, assessment for postoperative radiotherapy followed by randomization.
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
- 16 Years 至 69 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven soft tissue sarcoma that is amenable to definitive surgery no more than 8 weeks after biopsy or inadequate surgery
- •Eligible subtypes:
- •Alveolar soft part sarcoma
- •Angiosarcoma
- •Fibrosarcoma
- •Leiomyosarcoma
- •Malignant fibrous histiocytoma
- •Liposarcoma (round cell and pleomorphic)
- •Miscellaneous sarcoma (including pelvic mixed mesodermal tumors)
- •Malignant paraganglioma
- •Neurogenic sarcoma
- •Rhabdomyosarcoma
- •Synovial sarcoma
- •Unclassifiable sarcoma
- •Ineligible subtypes:
- •Chondrosarcoma
- •Dermatofibrosarcoma
- •Embryonal rhabdomyosarcoma
- •Ewing's sarcoma
- •Kaposi's sarcoma
- •Liposarcoma (myxoid and well differentiated)
- •Malignant mesothelioma
- •Neuroblastoma
- •Osteosarcoma
- •Confirmed high-grade tumor (i.e., Trojani Grade II or III)
- •No metastases on staging with chest x-ray and thoracic CT scan
- •No regional lymph node involvement
- •Locally recurrent disease allowed
- •Interval of 3 months or more between definitive surgery and recurrence
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 4,000/mm^3
- •Platelet count greater than 120,000/mm^3
- •No bleeding disorders
- •Bilirubin no greater than 1.25 times normal
- •No severe hepatic dysfunction
- •Creatinine less than 1.6 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No clear history of angina
- •No documented myocardial infarction
- •No existing cardiac failure
- •No serious infection
- •No other malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
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排除标准
- 未提供