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

NCT ID: NCT01487226

Last Updated: 2011-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Cervical Cancer

Keywords

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Cervical cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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paclitaxel

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

Intervention Type DRUG

Cisplatin 50mg/m2

Cisplatin 50mg/m2

Repeat every 3 weeks \* 6 cycles

Intervention Type DRUG

Other Intervention Names

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Cisplatin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Korean Gynecologic Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Taek Sang Lee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Kyung-Hee University East-West Med. Center

Locations

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KGOG

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Eunkyung Park

Role: CONTACT

Phone: 8225125420

Email: [email protected]

Facility Contacts

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Eunkyung Park

Role: primary

Other Identifiers

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KGOG1012

Identifier Type: -

Identifier Source: org_study_id