NCT04135521

Brief Summary

To compare dose-dense chemotherapy with intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

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

First Submitted

Initial submission to the registry

October 19, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 28, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

October 19, 2019

Last Update Submit

June 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Progression-free survivals between this intraveous and intraperitoneal chemotherapy groups

    months

    10 years

Secondary Outcomes (1)

  • Overall survivals between this two groups

    10 years

Interventions

Intraperitoneal or intravenous dose-dense platinum/taxane chemotherapy

Also known as: Intravenous dose-dense chemotherapy

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsadvanced ovarian cancer woman
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive women, who underwent intravenous dose-dense or intraperitoneal chemotherapy as the front-line chemotherapy were reviewed.

You may qualify if:

  • Women with FIGO stage II\~IV ovarian cancer
  • At least one cycle of intravenous dose-dense or intraperitoneal chemotherapy had been administered as the front-line chemotherapy.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Obstetrics & Gynecology, Associate Professor

Study Record Dates

First Submitted

October 19, 2019

First Posted

October 22, 2019

Study Start

October 28, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations