Soft Tissue Sarcoma
Conditions
Brief summary
This study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).
Detailed description
This phase II study is designed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO) for the first-line treatment of patients with advanced or metastatic soft tissue sarcoma (STS).
Interventions
DRUGPLD and IFO
PLD 30 mg/m2, d1, plus IFO 1.8 g/m2, d1-5
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* aged 18-70 years with histologically confirmed advanced or metastatic STS * Eastern Cooperative Oncology Group performance status of 0 to 2 * life expectancy of ≥ 3 months * have not received chemotherapy before * at least one measurable lesion * LVEF≥50% * have adequate bone marrow, hepatic, and renal function
Exclusion criteria
* osteosarcoma, Ewing's sarcoma/PNET (primitive neurotodermal tumour),GIST(Gastrointestinal Stromal Tumors), rhabdomyosarcoma, dermatofibrosarcoma protuberans * patients with symptomatic brain metastases * active clinical severe infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate | 2 months |
| overall survival | 12 months |
| Adverse Events | 2 months |
| biomarker analysis | 6 months |
Countries
China
Outcome results
None listed