Localized Non-Rhabdomyosarcoma Soft Tissue Sarcomas
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 250
- 试验地点
- 55
- 主要终点
- Local relapse-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase III trial is studying how well giving ifosfamide and doxorubicin, radiation therapy, and/or surgery works in treating young patients with localized soft tissue sarcoma.
详细描述
OBJECTIVES:
Primary
- Determine survival rates (event-free survival and overall survival [OS]) and the pattern of treatment failure in patients with synovial sarcoma or adult-type soft tissue sarcoma treated with ifosfamide and doxorubicin hydrochloride, radiotherapy, and/or surgery.
- Determine the role of ifosfamide and doxorubicin hydrochloride in improving the response rate in patients with unresectable synovial sarcoma or adult-type soft tissue sarcoma.
Secondary
- Evaluate clinical/pathological prognostic factors, particularly tumor grade and radiological and pathological response to neoadjuvant treatment.
- Determine the impact of omitting adjuvant chemotherapy in patients with low-risk synovial sarcoma (tumor < 5 cm).
- Determine the role of adjuvant chemotherapy in improving the metastases-free survival and OS in patients with adult-type soft tissue sarcoma (Intergroup Rhabdomyosarcoma Study [IRS] postsurgical grouping system I-II, tumor grade 3, tumor size > 5 cm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed synovial sarcoma or adult-type soft-tissue sarcoma
- •Adult-type soft tissue sarcoma includes any of the following:
- •Fibrosarcoma (adult-type)
- •No infantile fibrosarcoma
- •Malignant peripheral nerve sheath tumor
- •Malignant schwannoma
- •Neurofibrosarcoma
- •Epithelioid sarcoma
- •Leiomyosarcoma
- •Clear cell sarcoma
- •Liposarcoma
- •Alveolar soft-part sarcoma
- •Malignant fibrous histiocytoma
- •Hemangiopericytoma
- •Angiosarcoma
- •Dermatofibrosarcoma protuberans
- •Mesenchymal chondrosarcoma
- •No borderline tumors (e.g., hemangioendothelioma)
- •No small round cell tumors (e.g., extraosseous Ewing's sarcoma/primitive neuroectodermal tumor or desmoplastic small round cell tumor)
- •Post-irradiation soft-part sarcomas allowed
- •Diagnostic surgery performed within the past 8 weeks (for patients who require adjuvant chemotherapy)
- •No evidence of metastatic disease
- •Involved locoregional lymph nodes are allowed
- •PATIENT CHARACTERISTICS:
- •No prior malignancy
- •No pre-existing illness precluding study treatment*
- •Normal renal function (nephrotoxicity grade 0-1)*
- •No history of cardiac disease*
- •Normal shortening fraction (> 28%)*
- •Ejection fraction > 47%* NOTE: * For patients who require adjuvant chemotherapy
- •PRIOR CONCURRENT THERAPY:
- •No prior cancer treatment except primary surgery
排除标准
- 未提供
结局指标
主要结局
Local relapse-free survival
Event-free survival
Metastases-free survival
Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease)
Overall survival
次要结局
未报告次要终点