PLD and IFO As First-line Treatment for Patients With Advanced or Metastatic STS

Fudan University40 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Soft Tissue Sarcoma

Interventions

PLD and IFODRUG

PLD 30 mg/m2, d1, plus IFO 1.8 g/m2, d1-5

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

progression free survival

Time frame: 6 months

Secondary Outcomes

overall response rate

Time frame: 2 months

overall survival

Time frame: 12 months

Adverse Events

Time frame: 2 months

biomarker analysis

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.