NCT03562533

Brief Summary

This retrospective multicenter study aimed to evaluate the effectiveness of pegylated liposomal doxorubicin (PLD) with carboplatin (CD) compared with carboplatin and paclitaxel (CP) in patients who had disease progression longer than 6 months after first-line platinum+taxane chemotherapy for ovarian cancer in real world clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
432

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 17, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

May 23, 2018

Last Update Submit

February 26, 2019

Conditions

Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    OS was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive.

    36 months

Secondary Outcomes (3)

  • Progression free survival (PFS)

    3years

  • Incidence of Treatment-Related Adverse Events

    36 months

  • Response rate

    36 months

Study Arms (2)

pegylated liposomal doxorubicin + carboplatin

carboplatin area under the curve \[AUC\] 5 plus pegylated liposomal doxorubicin (PLD) 30 mg/m2 every 4 weeks

Drug: pegylated liposomal doxorubicin (PLD) + carboplatin (CD)

paclitaxel + carboplatin

carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks

Drug: carboplatin + paclitaxel (CP)

Interventions

pegylated liposomal doxorubicin (PLD) + carboplatin (CD)DRUG

carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles

pegylated liposomal doxorubicin + carboplatin
carboplatin + paclitaxel (CP)DRUG

carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles

paclitaxel + carboplatin

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A histologically confirmed diagnosis of epithelial ovarian, tubal, and primary peritoneal cancer, and recurred \>6 months after first-line platinum-based chemotherapy regimen

You may qualify if:

  • Previous taxane therapy was required.
  • Recurred \>6 months after surgery and first-line platinum-based chemotherapy regimen
  • Patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) or CA-125 assessable disease according to Gynecologic Cancer InterGroup (GCIG) criteria or histologic proven diagnosis
  • Eastern Cooperative Oncology Group performance status of ≤ 2

You may not qualify if:

  • Had ovarian tumors of low malignant potential (borderline tumors); nonepithelial or mixed epithelial/nonepithelial tumors (eg, mixed Mullerian tumors)
  • Had received prior radiotherapy; or, had a previous diagnosis of malignancy within the past 5 years.
  • Had bowel obstruction or presence of symptomatic brain metastases
  • Patients with severe active infection
  • Had history of severe hypersensitivity reactions to compounds chemically related to study products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University School of Medicine

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Park SJ, Kim J, Kim HS, Lee JW, Chang HK, Lee KH, Kim DY, Kim S, Chang SJ, Han SS, Park SY, Shim SH. Real world effectiveness and safety of pegylated liposomal doxorubicin in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer: a Korean multicenter retrospective cohort study. J Gynecol Oncol. 2020 Mar;31(2):e15. doi: 10.3802/jgo.2020.31.e15. Epub 2019 Sep 10.

    PMID: 31912673DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

liposomal doxorubicin1-dodecylpyridoxalCarboplatinCP protocol

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Seung Hyuk Shim, MD

    Konkuk University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 19, 2018

Study Start

May 17, 2018

Primary Completion

December 17, 2018

Study Completion

December 17, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)