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

Phase 2

• Conditions: Cervical Cancer

• Registration Number: NCT01487226
• Lead Sponsor: Korean Gynecologic Oncology Group

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 available

Study Timeline

• Study Start: 2008-01
• Status Verified: 2011-12
• Study First Submitted: 2011-12-04
• Study First Submitted QC: 2011-12-06
• Last Update Submitted: 2011-12-06
• Study First Posted: 2011-12-07
• Last Update Posted: 2011-12-07
• Primary Completion: 2015-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier

Secondary Outcome Measures

Name	Time	Method
log-rank test Cox regression analysis

Trial Locations

Locations (1)

KGOG; 🇰🇷 Seoul, Korea, Republic of