soft tissue sarcoma
Conditions
Interventions
Gemcitabine with Docetaxel Group: Gemcitabine with Docetaxel
Ifosfamide with Etoposide Group:Ifosfamide with Etoposide
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Patients with advanced soft tissue sarcoma confirmed by histopathology (except for well-differentiated liposarcoma, dedifferentiated liposarcoma, clear cell sarcoma, uterine stromal sarcoma, gastrointestinal stromal tumor, Kaposi's sarcoma); 2) Aged between 18 and 70 year-old; 3) Tumor progression after first-line chemotherapy; 4) ECOG score 0-2; 5) Patients are at least 4 weeks apart from the end of other anti-tumor treatments; 6) Have at least one measurable site of disease thah the maximum diameter must be = 1cm based on Spiral CT examination; 7) No major surgery in 28 days; 8) No other serious illness; 9) Female patient is not in pregnancy or lactation and agrees to take contraceptive measures during the trial; 10) Did not participate in other clinical trials within 3 months; 11) Expected survival time = 6months; 12) Peripheral blood tests before treatment meet the following criteria:ANC>1.5×10^9/L,PLT>80×10^9/L; 13) Liver and renal tests must meet the following criteria: TBIL=1.5×ULN; ALT/AST=1.5×ULN and Cr=1×ULN; 14) The participants should sign the informed consent forms.
Exclusion criteria
Exclusion criteria: 1) History of other malignancies (except fully treated basal cell carcinoma of the skin, cervical carcinoma in situ); 2) No evidence of distant metastasis from clinical examinations or imaging studies; 3) The patient's previous chemotherapy regimen included docetaxel, gemcitabine, etoposide,and ifosfamide; 4) Uncontrolled active infection; 5) women of childbearing age with positive pregnancy test; 6) Comobidities or conditions affect patients' normal enrollment or safety during study period; 7) Active mental disorders or other mental disorders that affect patients' ability to sign informed consent and understanding; 8) Anyone who to be considered not suitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Adverse events, AE;Quality of life, QoL; | — |
Countries
China
Contacts
Public ContactLi Mei
West China Hospital, Sichuan University
Outcome results
None listed