NCT00001189已完成2 期
The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.
详细描述
This is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.
Arm I: Radiotherapy. Involved-field irradiation.
Arm II: No further treatment.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Biopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors:
- •Abdominal and extra-abdominal fibromatosis (desmoid,
- •aggressive fibromatosis),
- •Dermatofibrosarcoma protuberans,
- •Intramuscular lipoma (infiltrating lipoma),
- •Diffuse lipomatosis,
- •Leiomyoma of deep soft tissue,
- •Diffuse giant cell tumor of tendon sheath (proliferative synovitis).
- •No clinical evidence of metastases in regional nodes or more distant sites.
- •No primary intraperitoneal or retroperitoneal tumors.
- •Resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative).
- •No von Recklinghausen's disease.
- •PRIOR/CONCURRENT THERAPY:
- •Biologic Therapy: Not specified.
- •Chemotherapy: No prior chemotherapy for sarcoma.
- •Endocrine Therapy: Not specified.
- •Radiotherapy: No prior radiotherapy for sarcoma.
- •Surgery: No more than 4 months since definitive surgery for
- •primary lesion or recurrence.
- •No prior amputation.
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over.
- •Performance status: Not specified.
- •Hematopoietic: Not specified.
- •Hepatic: No cirrhosis.
- •Renal: No evidence of severe renal impairment.
- •Cardiovascular: No ischemic heart disease.
- •No prior malignancy except basal cell carcinoma.
- •No serious infection.
- •No active bleeding disorder.
- •No severe concomitant disease.
排除标准
- 未提供
研究者
研究点 (1)
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