Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05109494
Eligibility Criteria:
Inclusion Criteria:
* Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck
* No prior sarcoma-directed chemotherapy or radiotherapy
* Age ≥ 18 years
* Karnofsky performance status ≥ 60
* Able to understand and sign an informed consent
* Life expectancy of greater than 12 weeks
* Hypofractionated or conventionally fractionated radiotherapy using Intensity Modulated Radiation Therapy (IMRT) are both deemed feasible and safe neoadjuvant treatments, at the treating physician's discretion
* Operable disease and medically fit for surgery, based on the opinion of the consulting surgeon; surgery within 5-14 days of completion of radiation therapy (RT)
* Adequate bone marrow function as defined by absolute neutrophil count \> 500/mcL, hemoglobin \> 8 g/dL, platelets \> 50,000/mcL; adequate renal function as defined by creatinine clearance \> 30 mL/min
Exclusion Criteria:
* Pregnant
* Unable to undergo imaging or positioning necessary for radiotherapy planning
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05109494
Study Brief:
Protocol Section:
NCT05109494