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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT04037527
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a histologically or cytologically confirmed Grade II or III soft tissue sarcoma that is considered to be resectable and are candidates for pre-op radiation.
* Age greater than or equal to 18 years. No children will be enrolled on this protocol.
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients taking concurrent hormonal therapy, biologic or other chemotherapy are excluded except women on hormonal contraceptives.
* Patients taking an investigational agent are excluded.
* Pregnant and nursing women are excluded.
* Patients who require amputation for local control.
* Patients who underwent unplanned excision or other previous surgery involving the affected extremity.
* Patients with sarcoma subtypes for which established chemotherapeutic regimens exist.
* History of radiation to the limb.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04037527
Study Brief:
Protocol Section:
NCT04037527