NCT03268772

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

5.7 years

First QC Date

August 30, 2017

Last Update Submit

April 21, 2020

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    6 months

Secondary Outcomes (4)

  • overall response rate

    2 months

  • overall survival

    12 months

  • Adverse Events

    2 months

  • biomarker analysis

    6 months

Study Arms (1)

PLD-IFO

EXPERIMENTAL

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

Drug: PLD and IFO

Interventions

PLD and IFODRUG

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

PLD-IFO

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • osteosarcoma, Ewing's sarcoma/PNET (primitive neurotodermal tumour),GIST(Gastrointestinal Stromal Tumors), rhabdomyosarcoma, dermatofibrosarcoma protuberans
  • patients with symptomatic brain metastases
  • active clinical severe infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • 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.

    PMID: 36239473DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

1-dodecylpyridoxal

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice professor

Study Record Dates

First Submitted

August 30, 2017

First Posted

August 31, 2017

Study Start

April 1, 2015

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)