Bacterial Decolonization Plus Intraoperative Angiography for Soft Tissue Sarcomas Receiving Preoperative Radiotherapy (CONCERTO)

Официальное название

Bacterial Decolonization Plus Intraoperative Indocyanine Green Angiography for Soft Tissue Sarcomas of the Lower Extremity Receiving Preoperative Radiotherapy (CONCERTO)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 2% intranasal mupirocin ointment
  Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.
• Препарат 4% chlorhexidine gluconate body cleanser
  Chlorhexidine Gluconate (CHG) Solution Antiseptic Skin Cleanser solution is a topical skin cleanser that keeps working after it is used. CHG is a strong antiseptic (liquid used to kill germs and bacteria) that lowers the risk of infection.

Первичные конечные точки

• Incidence and type of acute major wound complications [Срок оценки: Up to 24 months]

Вторичные конечные точки (9)

• 1-year Local control [Срок оценки: At 1 year]
• 2-year Local control [Срок оценки: At 2 years]
• Progression-free survival (PFS) [Срок оценки: Up to 24 months]
• Overall survival (OS) [Срок оценки: Up to 24 months]
• Musculoskeletal Tumour Society Score [MSTS] [Срок оценки: Up to 24 months]
• Toronto Extremity Salvage Score [TESS] [Срок оценки: Up to 24 months]
• Adverse Events and Serious Adverse Events related to intervention(s) [Срок оценки: Up to 24 months]
• Frequency of late toxicities [Срок оценки: Up to 24 months]
• Change in type of actual surgical closures [Срок оценки: At surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UPMC Hillman Cancer Centers — Pittsburgh

Идентификаторы

NCT: NCT06712433 · HCC 24-080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗