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:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT00864032
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed soft-tissue sarcoma located on the extremity or body wall.
* Intermediate or High grade (NCI grade 2 or 3/3-tier system), \> 5 cm in maximal dimension.
* Low grade (NCI grade 1/3-tier system), \> 8 cm in maximal dimension.
* No evidence of regional or distant metastatic disease.
* Patient must be 18 years of age or older.
* Patient must have an ECOG performance status of ≤ 2.
* Patient must have a histologic diagnosis of soft tissue sarcoma.
* Patient must have adequate bone marrow, liver, and renal function as assessed by the following:
* Hemoglobin ≥ 9.0 g/dl
* Absolute neutrophil count (ANC) ≥ 1,500/mm3
* Platelets ≥ 100,000/mm3.
* Total bilirubin ≤ 1.5 mg/dL. NOTE: Patients with elevated bilirubin secondary to Gilbert's syndrome are eligible to participate in the study.
* AST and ALT ≤ 2.5 times the institution upper limit of normal (ULN).
* Creatinine ≤ 1.5 times ULN.
* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the start of treatment . NOTE: Postmenopausal women must be amenorrheic for at least 12 months to be deemed not of reproductive potential.
* Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
* Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
* INR \< 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
Exclusion Criteria:
* Patient is receiving additional cancer-directed therapy at time of entry into trial.
* Patient has received or is receiving preoperative investigational treatment.
* Patient has congestive heart failure \> class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
* Patient has history of cardiac ventricular arrhythmia requiring ongoing anti-arrhythmic therapy.
* Patient has uncontrolled hypertension, defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
* Patient has known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
* Patient has active clinically serious infection \> CTCAE Grade 2.
* Patient has thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
* Patient has history of pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug.
* Patient has history of any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
* Patient has history of clinical or laboratory evidence of bleeding diathesis or coagulopathy.
* Patient has history of major surgery or significant traumatic injury within 4 weeks of first study drug.
* Patient has concomitant use of St. John's Wort or rifampin (rifampicin).
* Patient has known or suspected allergy to sorafenib or any agent given in the course of this trial.
* Patient has any condition that impairs his or her ability to swallow whole pills.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00864032
Study Brief:
Protocol Section:
NCT00864032