PLD and IFO As First-line Treatment for Patients With Adv... | NCT03268772

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

NCT03268772

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Apr 22, 2020Actual

Enrollment

40Actual

Phase

Phase 2

Conditions

Soft Tissue Sarcoma

Interventions

PLD and IFO

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2015Actual

Primary Completion Date

Nov 30, 2020Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Aug 30, 2017

First Submission Date that Met QC Criteria

Aug 30, 2017

First Posted Date

Aug 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2020

Last Update Posted Date

Apr 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PLD-IFO	Experimental	pegylated liposomal doxorubicin (PLD) combined with ifosfamide (IFO)	Drug: PLD and IFO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PLD and IFO	Drug	PLD 30 mg/m2, d1, plus IFO 1.8 g/m2, d1-5	PLD-IFO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival		6 months

Secondary Outcomes

Measure	Description	Time Frame
overall response rate		2 months
overall survival		12 months
Adverse Events

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center		Shanghai	Shanghai Municipality	200032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36239473	Derived	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.

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms