Phase II Study of Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance, Small Safety-margins and Brachytherapy Conditioned by Resection Margin
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Wound Complication Rate
研究概览
简要总结
RATIONALE: Modern radiotherapy techniques in a neoadjuvant setting have the potential to minimize morbidity and maximize efficacy. An additional boost dose can be provided locally by HDR-brachytherapy in patients with positive margins after tumor resection.
PURPOSE: This phase II trial is studying the safety and efficacy of a combination of modern radiotherapy elements applied to the tumor and small volumes of surrounding normal tissue (IMRT, IGRT; brachytherapy in case of positive resection margin) and see how well it works in treating patients with High-Risk Soft Tissue Sarcoma of the Extremities.
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
- •Histologic and radiographic proof of localized high-risk soft tissue sarcoma meeting the following criteria:
- •Lesion originates in extremity
- •upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips
- •lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
- •AJCC Stage II or III disease (except T1a-tumors or N1)
- •Primary presentation or local recurrence
- •after biopsy or inadequate surgery resulting in residual tumor in cross-sectional imaging
- •Tumors must be considered resectable according to cross sectional imaging, or potentially resectable after preoperative radiotherapy
- •ECOG Performance Status 0-2
- •Informed Consent
排除标准
- •Diagnosis of the following:
- •Primitive neuroectodermal tumor
- •Soft tissue Ewing's sarcoma
- •Extraskeletal osteo- or chondrosarcoma
- •Aggressive fibromatosis (desmoid tumors)
- •Dermatofibrosarcoma protuberans
- •Regional nodal disease or unequivocal distant metastasis
- •Life expectancy < 1 year
- •Pregnancy
- •Major medical illness that would preclude study treatment
- •History of major wound complication or recurrent skin infection
- •Known HIV positivity
- •< 2 weeks elapsed from prior surgery or cytotoxic chemotherapy
- •persisting acute toxicities > grade 1 in tumor-bearing limb resulting from prior treatment with anti-cancer modalities
- •Cytotoxic chemotherapy, targeted therapy or investigational agents concurrent to study treatment
- •Prior radiotherapy to the site of present STS.
- •Chronic requirement for treatment with immuno¬suppressive agents or steroids.
研究组 & 干预措施
1 Arm
Stratum A:
R0, primary wound closure
Stratum B:
R0, secondary wound closure
Stratum C:
R1, tertiary wound closure
干预措施: IMRT/IGRT, Tumor resection, Brachytherapy (Radiation)
结局指标
主要结局
Wound Complication Rate
时间窗: 3 months
Wound Complication Rate up to 3 months after tumor resection
次要结局
- Efficacy(2 years)
- Safety(2 years)
- Limb Functionality(2 years)
- Quality of Life(2 years)
- Translational(2 years)