NCT03019315

Brief Summary

Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer. The benefit of standard chemotherapeutic regimens including taxane has not been established. This study was conducted to investigate the influences of regimens of front-line chemotherapy on on recurrence and survival for early-stage ovarian adenocarcinoma. Further, the study will analyze cost-effectiveness of different regimens

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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

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

January 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

5.9 years

First QC Date

January 10, 2017

Last Update Submit

January 12, 2017

Conditions

Ovarian Cancer

Keywords

Ovarian CancerChemotherapyResponse RateSurvival

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    5 years

Secondary Outcomes (2)

  • over all survival

    5 years

  • response rate

    6 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ovarian cancer patients diagnosed between 1 January 1999 and 31 December 2020 without a history of cancer were identified from the catastrophic illness registry.

You may qualify if:

  • (1) diagnosed at early stage, (2) treated with primary cytoreductive surgery followed by adjuvant platinum based chemotherapy

You may not qualify if:

  • (1)patients with a history of cancer (2)patients had insufficient clinic-pathological and survival data regarding to disease prognosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

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

Study Officials

  • Wen-Fang Cheng, Ph.D.

    Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-Cheng Chiang, Ph.D.

CONTACT

886-2-2312-3456littlechiang1878@yahoo.com.tw

Wen-Fang Cheng, Ph.D.

CONTACT

886-2-2312-3456wenfangcheng@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

January 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 16, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)