A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 17
- 主要终点
- Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria
研究概览
简要总结
RATIONALE: Image-guided radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a lower dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying the side effects and how well image-guided radiation therapy works in treating patients with primary soft tissue sarcoma of the shoulder, arm, hip, or leg.
详细描述
OBJECTIVES:
Primary
- To determine the effect of reduced radiation volume using image-guided radiotherapy (IGRT) on lymphedema ≥ grade 2, subcutaneous fibrosis, and joint stiffness at 2 years in patients with primary soft tissue sarcoma of the extremity.
Secondary
- To estimate the rates of other grade 3-5 adverse events as measured by Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.
- To determine the pattern of first failure, including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.
- To estimate the rates of local failure, local-regional failure, distant failure, distant disease-free survival, disease-free survival, overall survival, and second primary tumor.
- To estimate the rate of wound complications.
- To correlate the degree of late radiation morbidity (defined as any lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years with scores on the clinical measure, Musculoskeletal Tumor Rating Scale (MSTS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A - Chemotherapy
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
干预措施: Chemotherapy (Drug)
Cohort A - Chemotherapy
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
干预措施: Radiation therapy (Radiation)
Cohort A - Chemotherapy
Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
干预措施: Surgery (Procedure)
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
干预措施: Radiation therapy (Radiation)
Cohort B - No Chemotherapy
Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
干预措施: Surgery (Procedure)
结局指标
主要结局
Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria
时间窗: 2 years after start of treatment (+/- 3 months)
The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.
次要结局
- Pattern of First Failure(From registration to date of local, regional or distant progression. Report at time of primary outcome measure analysis.)
- Distant Disease-free Survival Rate at Two Years(From registration to date of failure (distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.)
- Disease-free Survival Rate at Two Years(From registration to date of failure (local, regional or distant progression or death) or last follow-up. Report at time of primary outcome measure analysis.)
- Overall Survival Rate at Two Years(From registration to date of death or last follow-up. Report at time of primary outcome measure analysis.)
- Local Failure Rate at Two Years(From registration to date of failure (local progression) or death or last follow-up. Report at time of primary outcome measure analysis.)
- Second Primary Tumor Rate at Two Years(From registration to date of failure (second primary tumor) or death or last follow-up. Report at time of primary outcome measure analysis.)
- Late Radiation Morbidity Rate (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by CTCAE v3.0(2 years after start of treatment (+/- 3 months))
- Percentage of Patients With Wound Complications(From date of surgery to 4 months post-surgery)
- Regional Failure Rate at Two Years(From registration to date of failure (regional progression) or death or last follow-up. Report at time of primary outcome measure analysis.)
- Distant Failure Rate at Two Years(From registration to date of failure (distant progression) or death or last follow-up. Report at time of primary outcome measure analysis.)
- Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years(From start of treatment to 2 years.)
- Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events(From start of treatment to last follow-up. Analysis can occur at or after time of primary outcome measure analysis.)