Adjuvant Chemotherapy in Patients With Lymph Node Metasta... | NCT01487226

Studies
Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in Cervical Cancer

NCT01487226

Sponsor

Korean Gynecologic Oncology Group

Status

Unknown status

Last Update Posted

Dec 7, 2011Estimated

Enrollment

69Estimated

Phase

Phase 2

Conditions

Cervical Cancer

Interventions

paclitaxel
Cisplatin 50mg/m2

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

Dec 4, 2011

First Submission Date that Met QC Criteria

Dec 6, 2011

First Posted Date

Dec 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2011

Last Update Posted Date

Dec 7, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Taek Sang Lee, Principal Investigator, Korean Gynecologic Oncology GroupPrincipal Investigator

Lead Sponsor

Korean Gynecologic Oncology GroupOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
paclitaxel	Drug	Paclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks * 6 cycles
Cisplatin 50mg/m2	Drug	Cisplatin 50mg/m2 Repeat every 3 weeks * 6 cycles		Cisplatin

Measure	Description	Time Frame
Kaplan-Meier

Measure	Description	Time Frame
log-rank test Cox regression analysis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patients with grade 2 peripheral neuropathy
patients with uncontrolled infection

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eunkyung Park	Contact	8225125420		koreagynonco@gmail.com

Overall Officials

Name	Affiliation	Role
Jong Min Lee, MD	Kyung-Hee University East-West Med. Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KGOG	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017239	Paclitaxel
D002945	Cisplatin

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided