Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Wound Complication Rate
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying the side effects of intensity-modulated radiation therapy and to see how well it works in treating patients undergoing surgery for stage IB, stage II, or stage III soft tissue sarcoma.
详细描述
OBJECTIVES:
Primary
- Estimate the wound complication rate in patients with stage IB-III soft tissue sarcoma (STS) treated with neoadjuvant intensity-modulated radiotherapy (IMRT).
Secondary
- Assess local control rate in patients treated with this regimen.
- Assess metastatic failure rate in patients treated with this regimen.
- Assess disease-free survival of patients treated with this regimen.
- Assess overall survival of patients treated with this regimen.
- Assess function and general health in these patients using the Musculoskeletal Tumor Society rating scale, Toronto Extremity Salvage Score, and the Short-Form 36.
- Determine changes in STS gene expression after IMRT by microarray analyses.
- Correlate, preliminarily, changes in STS gene expression with pathological and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 soft tissue sarcoma (STS) for which neoadjuvant or adjuvant radiotherapy is considered standard care
- •Stage IB-III disease
- •Primary or locally recurrent disease
- •The following chemotherapy-sensitive STS histologies are excluded:
- •Primitive neuroectodermal tumor
- •Desmoplastic small round cell tumor
- •Synovial sarcoma
- •Myxoid round cell liposarcoma
- •Angiosarcoma
- •No sarcomas for which surgical staging and adjuvant radiotherapy are considered standard care (e.g., uterine sarcomas, including leiomyosarcoma, malignant mixed Müllerian tumors, and endometrial stromal sarcoma)
- •No retroperitoneal STS
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Able to complete the self-assessment questionnaires (may use translator service)
- •Willing and able to undergo pre-treatment core needle biopsies
- •Negative pregnancy test
- •No known HIV positivity
- •PRIOR CONCURRENT THERAPY:
- •Prior adjuvant chemotherapy for STS allowed provided patient has locally recurrent disease
- •At least 1 year since prior adjuvant chemotherapy
- •No prior radiotherapy to the site of present STS
- •No other concurrent cytotoxic chemotherapy, targeted therapy, or investigational agents
排除标准
- 未提供
结局指标
主要结局
Wound Complication Rate
时间窗: 1 year
Major wound complications up to 4 months post surgery include: Complications requiring a secondary operation under general or regional anesthesia for wound care. Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days.
次要结局
未报告次要终点