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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma,Soft Tissue
• Intervention / Treatment: Drug: 2% intranasal mupirocin ointment; Drug: 4% chlorhexidine gluconate body cleanser

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.

• Study Type: Interventional
• Enrollment (Estimated): 31
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Brieanna Marino, MS; Phone Number: 412-647-8258; Email: rowlesbm@upmc.edu
• Study Contact Backup: Name: Samantha Demko, RN; Phone Number: 412-623-1400; Email: albesl@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Centers
      • Principal Investigator: Adam Olson, MD
      • Contact: Brieanna Marino, MS; Phone Number: 412-647-8258; Email: rowlesbm@upmc.edu
      • Contact: Samantha Demko, RN; Phone Number: 412-623-1400; Email: albesl@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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.; Other Names: Hibiclens®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and type of acute major wound complications	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.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year Local control	Local control is defined as the proportion of patients without clinical evidence of local recurrence. This will be reported as will a cumulative incidence curve of local failures, considering using death as a competing risk, using the cumulative incidence function method.	At 1 year
2-year Local control	Local control is defined as the proportion of patients without clinical evidence of local recurrence. This will be reported as will a cumulative incidence curve of local failures, considering using death as a competing risk, using the cumulative incidence function method.	At 2 years
Progression-free survival (PFS)	Median number of months from start of treatment until the date of disease progression or death from any cause.	Up to 24 months
Overall survival (OS)	Median number of months from start of treatment until death from any cause.	Up to 24 months
Musculoskeletal Tumour Society Score [MSTS]	The MSTS is a patient questionnaire for assessing physical function after medical treatment, surgery, and physiotherapy in patients with malignant bone tumors in specific extremities. The MSTS questionnaire consists of six domains, each scored on a scale from 0 to 5, with a higher score indicating better function. The total score, ranging from 0 (maximum disability) to 30 (no impairment), can be transformed to a point scale of 0 to 100.	Up to 24 months
Toronto Extremity Salvage Score [TESS]	TESS represents the gold standard for assessing function after surgery for muscle and bone tumors, as it has been tested for validity and reliability, and extremity-specifically defines disability, handicap, change in physical function depending on the therapeutic intervention and the patient's need for an aid. The TESS questionnaire has both upper and lower extremity versions. Twenty-nine items are rated on a scale from one to five, with five representing normal activity. The result ranges from 0 to 100, with 100 being the best score.	Up to 24 months
Adverse Events and Serious Adverse Events related to intervention(s)	Adverse Events and Serious Adverse Events per CTCAE v5.0 that attributed to study intervention(s).	Up to 24 months
Frequency of late toxicities	Acute toxicities are defined as toxicity occurring during preoperative RT, after RT and prior to surgery, and within 90 days of index resection, assessed using CTCAE v5.0.	Up to 24 months
Change in type of actual surgical closures	Tabulation of the initial surgical closure intended, and the actual surgical closure used at the time of index resection. Descriptive statistics will be used to summarize these assessments.	At surgery

Collaborators and Investigators

• Sponsor: Adam Olson
• Collaborators: Pittsburgh Cure Sarcoma
• Investigators: Principal Investigator: Adam M Olson, MD, UPMC Hillman Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: bacterial decolonization (BD); external beam radiotherapy (RT); wide local excision (WLE); intraoperative IICG angiography
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Synthesis Inhibitors; Anti-Infective Agents, Local; Disinfectants; chlorhexidine gluconate
• Other Study ID Numbers: HCC 24-080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No