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 @ 12:23 PM
Ignite Modification Date:
2025-12-24 @ 12:23 PM
NCT ID:
NCT00807261
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed recurrent or metastatic, unresectable soft tissue sarcoma or bone sarcoma with the exception of certain histopathologic subtypes of sarcomas recognized by experts to derive no benefit from conventional chemotherapy (e.g., alveolar soft part sarcoma, clear cell sarcoma, chondrosarcoma, chordoma, desmoid tumors)
* Bone sarcoma patients must have visceral metastatic disease (e.g., metastatic to lung or liver)
* Patients who were previously treated with anthracycline- and/or ifosfamide- containing chemotherapy, as a first-line chemotherapy for metastatic disease, or adjuvant therapy Patients may have had up to 2 prior chemotherapies within 4 weeks of starting the study treatment
* unidimensional measurable lesions
* Age ≥ 16 years
* Life expectancy of more than 3 months
* ECOG performance status ≤ 2
* Adequate bone marrow function (ANC≥1,500/mm3, and platelet count ≥100,000/mm3)
* Adequate kidney function (serum creatinine ≤ 1.5 mg/dL)
* Adequate liver function (bilirubin ≤ 2 mg/dl and transaminase level ≤ 3 times the upper normal limit, or \< 5 times for patients with liver metastasis, serum alkaline phosphatase \< 2.5 times the upper normal limit, or \< 5 times if liver metastases were present or \< 10 times if bone metastases were present).
* Adequate cardiac function (Ejection fraction ≥ 50% by echoCG or MUGA scan)
* All patients are fully informed about the nature and purpose of this study and should give informed consent before the start of treatment.
Exclusion Criteria:
* Pregnant or lactating patients
* Patients with resectable lung metastasis
* Presence or history of CNS metastasis
* Prior history of other cancer within past 5 years, asides from basal cell and squamous cell carcinoma of skin, and carcinoma in situ of uterine cervix
* Any preexisting medical condition of sufficient severity to prevent full compliance with the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00807261
Study Brief:
Protocol Section:
NCT00807261