Bacterial Decolonization Plus Intraoperative Indocyanine Green Angiography for Soft Tissue Sarcomas of the Lower Extremity Receiving Preoperative Radiotherapy (CONCERTO)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Adam Olson
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Incidence and type of acute major wound complications
研究概览
简要总结
This trial will investigate the combination of two low-cost, non-toxic strategies to assess whether they can reduce the risk of acute major wound complications in soft tissue sarcoma of the lower extremity. Intranasal mupirocin ointment twice daily and chlorhexidine body cleanser once daily for 5 days prior to radiation therapy and repeated for 5 days every 2 weeks during radiation therapy may significantly reduce the risk of acute radiation dermatitis. That, along with use of indocyanine green (ICG) angiography at the time of wound closure.
详细描述
Strategies to reduce the risk of acute wound complications have historically been mostly unsuccessful. In soft tissue sarcomas, a prior study showed that the use of indocyanine green (ICG) angiography at the time of wound closure was associated with a reduction in wound dehiscence and infection when compared to historical controls. Cutaneous colonization of S. aureus has been implicated in severe cases of radiation dermatitis. Some known risk factors for acute major wound complications for patients with sarcomas are anatomic location in the lower extremity, preoperative radiation therapy, larger tumors, comorbidities (e.g., diabetes mellitus, tobacco usage, vascular disease, and obesity), tumors <3mm from skin surface, and the development of grade ≥ 2 acute radiation dermatitis. Both large tumors and lower extremity location can increase the likelihood of seroma formation, which can act as a nidus for infection and subsequent wound complication. Rationale for this trial includes prior studies of treating patients with a bacterial decolonization (BD) protocol of intranasal mupirocin ointment twice daily and chlorhexidine body cleanser once daily for 5 days prior to RT and repeated for 5 days every 2 weeks during radiation therapy that show significantly reduced risk of acute radiation dermatitis.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •Newly diagnosed soft tissue sarcoma arising from the lower extremity (defined as the tumor center arising at the level of the iliac crest or below)
- •Eligible for wide local excision
- •Eligible for external beam radiation therapy
- •Negative serum pregnancy test for women of childbearing potential < 28 days prior to RT.
- •Informed consent signed and dated to participate in the study.
- •Willingness and ability to comply
排除标准
- •Allergy to mupirocin and/or chlorhexidine
- •Active dermatologic condition in RT field
- •Tumor size > 32cm
- •Prior RT overlapping with fields
- •Concurrent/prior invasive malignancy that could potentially interfere with proposed treatment. Individual cases can be discussed with PI prior to registration
研究组 & 干预措施
BD + Intranasal Mupirocin + Chlorhexidine
Bacterial Decolonization with 2% intranasal mupirocin ointment twice daily (BID) and 4% chlorhexidine gluconate body cleanser, once daily (QD) for 5 consecutive days prior to RT, and this will be repeated for 5 days every 2 weeks throughout Radiation Therapy.
The treatment will also be administered for 5 consecutive days prior to index surgery. RT can be prescribed in one of three dose/fractionation regimens at the investigator's discretion: 50 Gy in 25 fractions, 42.75 Gy in 15 fractions, or 36 Gy in 18 fractions
干预措施: 2% intranasal mupirocin ointment (Drug)
BD + Intranasal Mupirocin + Chlorhexidine
Bacterial Decolonization with 2% intranasal mupirocin ointment twice daily (BID) and 4% chlorhexidine gluconate body cleanser, once daily (QD) for 5 consecutive days prior to RT, and this will be repeated for 5 days every 2 weeks throughout Radiation Therapy.
The treatment will also be administered for 5 consecutive days prior to index surgery. RT can be prescribed in one of three dose/fractionation regimens at the investigator's discretion: 50 Gy in 25 fractions, 42.75 Gy in 15 fractions, or 36 Gy in 18 fractions
干预措施: 4% chlorhexidine gluconate body cleanser (Drug)
结局指标
主要结局
Incidence and type of acute major wound complications
时间窗: Up to 24 months
Incidence and type of acute major wound complications: One or more of the following events occurring within 4 months of index sarcoma surgery including: 1). A secondary operation under general or regional anesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts), 2). Wound management without secondary operation, such, An invasive procedure without general or regional anesthesia (such as aspiration of seroma), Readmission for wound care such as intravenous antibiotics, or Persistent deep packing for 120 days or longer.
次要结局
- 1-year Local control(At 1 year)
- Musculoskeletal Tumour Society Score [MSTS](Up to 24 months)
- Frequency of late toxicities(Up to 24 months)
- Overall survival (OS)(Up to 24 months)
- Adverse Events and Serious Adverse Events related to intervention(s)(Up to 24 months)
- Progression-free survival (PFS)(Up to 24 months)
- Toronto Extremity Salvage Score [TESS](Up to 24 months)
- Change in type of actual surgical closures(At surgery)
- 2-year Local control(At 2 years)
研究者
Adam Olson
Assistant Professor, Radiation Oncology
University of Pittsburgh