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

Adam Olson

Status and phase: Not yet enrolling; Phase 2

Conditions: Sarcoma,Soft Tissue

Treatments: Drug: 4% chlorhexidine gluconate body cleanser; Drug: 2% intranasal mupirocin ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT06712433

HCC 24-080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
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)
3. Eligible for wide local excision
4. Eligible for external beam radiation therapy
5. Negative serum pregnancy test for women of childbearing potential < 28 days prior to RT.
6. Informed consent signed and dated to participate in the study.
7. Willingness and ability to comply

Exclusion criteria

1. Allergy to mupirocin and/or chlorhexidine
2. Active dermatologic condition in RT field
3. Tumor size > 32cm
4. Prior RT overlapping with fields
5. Concurrent/prior invasive malignancy that could potentially interfere with proposed treatment. Individual cases can be discussed with PI prior to registration

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

BD + Intranasal Mupirocin + Chlorhexidine

Experimental group

Description:

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

Treatment:

Drug: 2% intranasal mupirocin ointment

Drug: 4% chlorhexidine gluconate body cleanser