Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in Cervical Cancer
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Cervical cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: paclitaxel Type: Drug
Name: Cisplatin 50mg/m2 Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 20 Years
Gender: Female
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
Location
KGOG
Seoul, Korea, Republic of
Status: Recruiting
Contact: Eunkyung Park - 8225125420 - koreagynonco@gmail.com
Start Date
January 2008
Completion Date
January 2015
Sponsors
Korean Gynecologic Oncology Group
Source
Korean Gynecologic Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page