A Phase II Surgical Trial Of Intralesional Resection Of Low-Grade Intracompartmental Chondrosarcoma Of Bone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 23
- 主要终点
- Probability of local complications
研究概览
简要总结
RATIONALE: Intralesional resection is a less invasive type of surgery for chondrosarcoma of the bone and may have fewer side effects and improve recovery.
PURPOSE: This phase II trial is studying how well intralesional resection works in treating patients with low-grade chondrosarcoma of the bone.
详细描述
OBJECTIVES:
- Determine the probability of local complications (e.g., fracture, nerve palsy, deep venous thrombosis, unexpected rehospitalization, unanticipated reoperation, or death within 2 years) in patients with suspected low-grade intracompartmental chondrosarcoma of the bone undergoing intralesional resection.
- Determine the 5-year probability of local recurrence and development of metastatic disease in patients undergoing this procedure.
- Determine the impact of musculoskeletal tumor reconstruction on the functional status of patients undergoing this procedure.
OUTLINE: This is a multicenter study.
Patients undergo intralesional resection (curettage with high-speed burr). Patients then receive local adjuvant treatment comprising liquid nitrogen, phenol, alcohol, or argon beam to the excision site. The bone cavity is then filled with either polymethyacrylate cement or a bone graft (allograft or homograft). Patients may also have a metal plate installed at the wound site.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
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:
- •Suspected low-grade intracompartmental chondrosarcoma, as defined by the following criteria:
- •Resorption of prior calcifications (indicated by a change in radiographic appearance over time) AND/OR meets at least 2, but no more than 4, of the following criteria:
- •Permeative appearance of medullary bone, defined as presence of tumor around 3 sides of a trabecula of normal bone
- •Endosteal scalloping, defined as > 50% of adjacent cortical thickness
- •Cortical thickening beyond the thickness of adjacent normal bone
- •Bone expansion, defined as a circumferential increase in diameter of the bone beyond the adjacent normal bone
- •Positive (i.e., increased uptake or "hot") bone scan
- •No cortical disruption and/or soft tissue mass by radiography and CT scan (3 mm cuts are optimal) or MRI
- •No presumptive axial (spinal) involvement
- •No multifocal disease by bone scan
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior biologic therapy for this tumor
- •Chemotherapy
- •No prior chemotherapy for this tumor
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy for this tumor
- •No prior surgery for this tumor except biopsy*
- •No concurrent intramedullary fixation NOTE: *Biopsy is not required
- •No prior investigational anticancer agents for this tumor
排除标准
- 未提供
研究组 & 干预措施
surgery
intralesional resection
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Probability of local complications
时间窗: two years
次要结局
- Probability of local recurrence and development of metastatic disease(5 years)
- Impact of musculoskeletal tumor reconstruction on functional status(two years)