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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Drug: PLD and IFO

Study type: Interventional

Funder types: Other

Identifiers

NCT03268772

CSPC-DMS-STS-01

Details and patient eligibility

About

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).

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

PLD-IFO

Experimental group

Description:

pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO)

Treatment:

Drug: PLD and IFO