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

Primary Purpose

Soft Tissue Sarcoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

PLD and IFO

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PLD-IFO

Arm Description

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

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

overall response rate

overall survival

Adverse Events

biomarker analysis

Full Information

NCT ID

NCT03268772

First Posted

August 30, 2017

Last Updated

April 21, 2020

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03268772

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2015 (Actual)

Primary Completion Date

November 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PLD-IFO

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PLD and IFO

Intervention Description

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

Primary Outcome Measure Information:

Title

progression free survival

Time Frame

6 months

Secondary Outcome Measure Information:

Title

overall response rate

Time Frame

2 months

Title

overall survival

Time Frame

12 months

Title

Adverse Events

Time Frame

2 months

Title

biomarker analysis

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36239473

Citation

Liu X, Jiang S, Wang H, Wu X, Yan W, Chen Y, Xu Y, Wang C, Yao W, Wang J, Yu L, Miao J, Chen H, Xia J, Huang M, Zhang X, Luo Z. Pegylated Liposomal Doxorubicin Combined with Ifosfamide for Treating Advanced or Metastatic Soft-tissue Sarcoma: A Prospective, Single-arm Phase II Study. Clin Cancer Res. 2022 Dec 15;28(24):5280-5289. doi: 10.1158/1078-0432.CCR-22-1785.

Results Reference

derived

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

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