PLD and IFO As First-line Treatment for Patients With Advanced or Metastatic STS
Phase 2
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Drug: PLD and IFO
- Registration Number
- NCT03268772
- Lead Sponsor
- Fudan University
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PLD-IFO PLD and IFO pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO)
- Primary Outcome Measures
Name Time Method progression free survival 6 months
- Secondary Outcome Measures
Name Time Method overall response rate 2 months biomarker analysis 6 months overall survival 12 months Adverse Events 2 months
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China