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Clinical Trials/NCT01487226
NCT01487226
Unknown
Phase 2

A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer

Korean Gynecologic Oncology Group1 site in 1 country69 target enrollmentJanuary 2008
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ConditionsCervical Cancer
DrugspaclitaxelCisplatin 50mg/m2

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
Korean Gynecologic Oncology Group
Enrollment
69
Locations
1
Primary Endpoint
Kaplan-Meier
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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
Registry
clinicaltrials.gov
Start Date
January 2008
End Date
January 2015
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Korean Gynecologic Oncology Group
Responsible Party
Principal Investigator
Principal Investigator

Taek Sang Lee

Principal Investigator

Korean Gynecologic Oncology Group

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

Outcomes

Primary Outcomes

Kaplan-Meier

Secondary Outcomes

  • log-rank test Cox regression analysis

Study Sites (1)

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