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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Drug 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.
• Drug 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.

Primary outcome measures

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

Secondary outcome measures (9)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• UPMC Hillman Cancer Centers — Pittsburgh

Identifiers

NCT: NCT06712433 · HCC 24-080

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗