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

Launched by ADAM OLSON · Nov 26, 2024

Keywords

ClinConnect Summary

The CONCERTO clinical trial is looking at how two simple and safe treatments can help reduce serious wound problems in patients with soft tissue sarcomas in the lower leg. The study will test using a special ointment (mupirocin) and a body wash (chlorhexidine) before and during radiation therapy to see if they can lower the risk of skin issues caused by the radiation. Additionally, the trial will use a technique called ICG angiography during surgery to help improve healing.

To participate in this trial, you need to be between 65 and 74 years old and have a newly diagnosed soft tissue sarcoma in the lower leg that can be surgically removed. You should also be eligible for radiation therapy and able to understand and sign the consent form to join the study. If you have certain allergies or skin issues in the treatment area, or if there are other health concerns, you may not be eligible. This trial is currently not recruiting participants, but it aims to provide valuable insights into improving care for patients undergoing treatment for this type of cancer.

Gender

ALL

Eligibility criteria

• 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