NCT01851746

Brief Summary

The purpose of this study is to evaluate the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 10, 2013

Status Verified

May 1, 2013

Enrollment Period

1.9 years

First QC Date

May 7, 2013

Last Update Submit

May 9, 2013

Conditions

Recurrent Ovarian Cancer

Keywords

recurrent ovarian cancerlobaplatindocetaxelcarboplatin

Outcome Measures

Primary Outcomes (1)

  • Evidence of the effectiveness and security of lobaplatin combined with docetaxel in treatment of the sensitive recurrent ovarian cancer.

    Blood routine, urine routine, hepatic and kidney function, electrolyte, ECG, CT,MRI

    from pre-chemotherapy to 4-6 weeks post-chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

residents of a certain town

You may qualify if:

  • age between 18 and 70 years old
  • singed the information consent form
  • Expected survival time \>3 months
  • Recurrence for at least 6 months after receiving initial platinum-based chemotherapy and without cytoreductive surgery indications.

You may not qualify if:

  • Recurrence within 6 months after receiving initial platinum-based chemotherapy
  • without radiographic evidence for tumor recurrence
  • receiving other chemotherapy, hormone therapy, immunotherapy, or radiation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Boold,Urine

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

  • Hong-bing Cai, MD,PhD

    Zhongnan Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of gynecologic oncology department of Zhongnan Hospital of Wuhan University

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 10, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 10, 2013

Record last verified: 2013-05

Locations

CN(1)