NCT01487226

Brief Summary

Purpose Primary endpoint

  • To evaluate the 3-year disease free survival Second endpoints
  • To evaluate the 3-year \& 5-year overall survival To analyze the toxicity and the quality of life

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
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 7, 2011

Status Verified

December 1, 2011

Enrollment Period

7 years

First QC Date

December 4, 2011

Last Update Submit

December 6, 2011

Conditions

Cervical Cancer

Keywords

Cervical cancer

Outcome Measures

Primary Outcomes (1)

  • Kaplan-Meier

Secondary Outcomes (1)

  • log-rank test Cox regression analysis

Interventions

paclitaxelDRUG

Paclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks \* 6 cycles

Cisplatin 50mg/m2DRUG

Cisplatin 50mg/m2 Repeat every 3 weeks \* 6 cycles

Also known as: Cisplatin

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cervical cancer stage Ia2-IIa
  • histology; squamous, adeno, adenosquamous subtype
  • age; 20∼70 years
  • performance status; GOG 0∼2
  • no medical illness
  • hematologic, renal, hepatic function; normal
  • grossly no residual disease
  • histologically confirmed lymph nodes metastases
  • no parametrial extension and negative resection margin
  • number of retrieved lymph nodes; ≥ 20

You may not qualify if:

  • patients with grade 2 peripheral neuropathy
  • patients with uncontrolled infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KGOG

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

PaclitaxelCisplatin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Jong Min Lee, MD

    Kyung-Hee University East-West Med. Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunkyung Park

CONTACT

8225125420koreagynonco@gmail.com

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
Principal Investigator

Study Record Dates

First Submitted

December 4, 2011

First Posted

December 7, 2011

Study Start

January 1, 2008

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

December 7, 2011

Record last verified: 2011-12

Locations

KR(1)