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

Soft Tissue Sarcoma Clinical Trial

Official title:

Pegylated-liposome Doxorubicin Combined With Ifosfamide As First-line Treatment for Patients With Advanced or Metastatic Soft Tissue Sarcoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03268772
• Other study ID #: CSPC-DMS-STS-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 1, 2015
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• PLD and IFO
PLD 30 mg/m2, d1, plus IFO 1.8 g/m2, d1-5

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		6 months
Secondary	overall response rate		2 months
Secondary	overall survival		12 months
Secondary	Adverse Events		2 months
Secondary	biomarker analysis		6 months