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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT01490060
Eligibility Criteria:
Inclusion Criteria:
1. Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with doxorubicin plus ifosfamide (AI) or AI and vincristine (VAI) is indicated.
2. Must be 18-65 years of age.
3. Male and Females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, us of a intrauterine device (IUD) or abstinence.
4. Adequate hematologic (ANC \>/= 1500/mm\^3, platelet count \>/= 100,000/mm\^3), renal (serum creatinine \</= 1.5 mg/dL), hepatic (serum bilirubin count \</= 1.5 x normal and SGOT or SGPT \</= 3 x normal) functions.
5. Karnofsky Performance Status \>/= 60%
6. Signed informed consent form.
7. Patients are required to read and understand English to comply with protocol requirements.
Exclusion Criteria:
1. Pregnant or lactating women.
2. Patients with any co-morbid condition which renders patients at high risk of treatment complication.
3. Known allergy to fosaprepitant or any of its active components.
4. Patient has uncontrolled angina, congestive heart failure (New York Heart Association \> class II or known ejection fraction \< 40%), uncontrolled cardiac arrhythmia or hypertension, or acute myocardial infarction within 3 months.
5. Patient has an active seizure disorder. (Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years).
6. Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
7. Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.
8. Patients receiving any medication for pre-existing nausea/vomiting will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01490060
Study Brief:
Protocol Section:
NCT01490060