A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer
Phase 2
20 Years
70 Years
20 Years
70 Years
Open (Enrolling)
Female
Cervical Cancer
Female
Cervical Cancer
Trial Information
A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Kaplan-Meier
Principal Investigator
Jong Min Lee, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Kyung-Hee University East-West Med. Center
Authority:
Korean: Food and Drugs Administration
Study ID:
KGOG1012
NCT ID:
NCT01487226
Start Date:
January 2008
Completion Date:
January 2015
Related Keywords:
- Cervical Cancer
- Cervical cancer
- Uterine Cervical Neoplasms
- Neoplasm Metastasis
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