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Sarcoma,Soft TissuePhase 2CONCERTONCT06712433

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

A Phase 2 study testing 2% intranasal mupirocin ointment and 4% chlorhexidine gluconate body cleanser in people with Sarcoma,Soft Tissue, run by Adam Olson at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma,Soft Tissue
What is being tested?
2% intranasal mupirocin ointment and 4% chlorhexidine gluconate body cleanser
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
30 Sep 2026to 30 Sep 2028
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Hillman Cancer Centers

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
2% intranasal mupirocin ointment, 4% chlorhexidine gluconate body cleanser
Keywords
bacterial decolonization (BD), external beam radiotherapy (RT), wide local excision (WLE), intraoperative IICG angiography
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2% intranasal mupirocin ointmentDrug

    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.

  • 4% chlorhexidine gluconate body cleanserDrug

    Also called Hibiclens®

    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.

Study groups in NCT06712433
Study groupRoleWhat they receive
BD + Intranasal Mupirocin + ChlorhexidineExperimentalBacterial 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
Receives: Drug: 2% intranasal mupirocin ointment; Drug: 4% chlorhexidine gluconate body cleanser

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 months

Secondary outcomes (9)

  1. 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.

    Measured: At 1 year

  2. 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.

    Measured: At 2 years

  3. Progression-free survival (PFS)

    Median number of months from start of treatment until the date of disease progression or death from any cause.

    Measured: Up to 24 months

  4. Overall survival (OS)

    Median number of months from start of treatment until death from any cause.

    Measured: Up to 24 months

  5. 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.

    Measured: Up to 24 months

  6. 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.

    Measured: Up to 24 months

  7. 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).

    Measured: Up to 24 months

  8. 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.

    Measured: Up to 24 months

  9. 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.

    Measured: At surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Why it stopped: Per the PI, this study is not proceeding due to funding and insufficient support.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06712433
Sponsor's protocol ID
HCC 24-080
Acronym
CONCERTO
Status last verified
Feb 2026
First submitted
26 Nov 2024
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 2% intranasal mupirocin ointment and 4% chlorhexidine gluconate body cleanser in people with Sarcoma,Soft Tissue, run by Adam Olson at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and type of acute major wound complications (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06712433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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