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

NCT06712433 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCC 24-080
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma,Soft Tissue

Keywords

bacterial decolonization (BD); external beam radiotherapy (RT); wide local excision (WLE); intraoperative IICG angiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 1-year Local control

  At 1 year

• 2-year Local control

  At 2 years

• Progression-free survival (PFS)

  Up to 24 months

• Overall survival (OS)

  Up to 24 months

• Musculoskeletal Tumour Society Score [MSTS]

  Up to 24 months

Study Arms (1)

BD + Intranasal Mupirocin + Chlorhexidine

EXPERIMENTAL

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; Drug: 4% chlorhexidine gluconate body cleanser

Interventions

2% intranasal mupirocin ointment DRUG

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.

BD + Intranasal Mupirocin + Chlorhexidine

4% chlorhexidine gluconate body cleanser DRUG

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.

Also known as: Hibiclens®

BD + Intranasal Mupirocin + Chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adam Olson: lead
• Pittsburgh Cure Sarcoma: collaborator

Study Sites (1)

UPMC Hillman Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Adam M Olson, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Demko, RN

CONTACT

412-623-1400; albesl@upmc.edu

Brieanna Marino, MS

CONTACT

412-647-8258; rowlesbm@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Radiation Oncology

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)