Clinical trial NCT06712433: Bacterial Decolonization Plus Intraoperative Angiography for Soft Tissue Sarcomas Receiving Preoperative Radiotherapy (CONCERTO)
Official title: Bacterial Decolonization Plus Intraoperative Indocyanine Green Angiography for Soft Tissue Sarcomas of the Lower Extremity Receiving Preoperative Radiotherapy (CONCERTO)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Sarcoma,Soft Tissue
Keywords: bacterial decolonization (BD)
external beam radiotherapy (RT)
wide local excision (WLE)
intraoperative IICG angiography
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Pittsburgh Cure Sarcoma
First posted: 2024-12-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Incidence and type of acute major wound complications
timeFrame: Up to 24 months
Secondary outcomes:
measure: 1-year Local control
timeFrame: At 1 year
measure: 2-year Local control
timeFrame: At 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to 24 months
measure: Overall survival (OS)
timeFrame: Up to 24 months
measure: Musculoskeletal Tumour Society Score [MSTS]
timeFrame: Up to 24 months
measure: Toronto Extremity Salvage Score [TESS]
timeFrame: Up to 24 months
measure: Adverse Events and Serious Adverse Events related to intervention(s)
timeFrame: Up to 24 months
measure: Frequency of late toxicities
timeFrame: Up to 24 months
measure: Change in type of actual surgical closures
timeFrame: At surgery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Centers
state: Pennsylvania
Study officials:
affiliation: UPMC Hillman Cancer Center
name: Adam M Olson, MD
role: PRINCIPAL_INVESTIGATOR
References: