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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdam Olson

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Allergy to mupirocin and/or chlorhexidine

Active dermatologic condition in RT field

Tumor size > 32cm

Prior RT overlapping with fields

Trial design

Treatments tested in this trial

  • 2% intranasal mupirocin ointment
  • 4% chlorhexidine gluconate body cleanser

Treatment groups

31 Participants
are divided into 1 treatment group

Sponsors and collaborators

Adam Olson

Lead sponsor

University of Pittsburgh

Sponsor institution

Pittsburgh Cure Sarcoma

Collaborator