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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Korean Gynecologic Oncology Group
Sponsor:
Information provided by (Responsible Party):
Taek Sang Lee, Korean Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01487226
First received: December 4, 2011
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

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

Condition Intervention Phase
Cervical Cancer
Drug: paclitaxel
Drug: Cisplatin 50mg/m2
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Korean Gynecologic Oncology Group:

Primary Outcome Measures:
  • Kaplan-Meier

Secondary Outcome Measures:
  • log-rank test Cox regression analysis

Estimated Enrollment: 69
Study Start Date: January 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: paclitaxel
    Paclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks * 6 cycles
    Other Name: paclitaxel
    Drug: Cisplatin 50mg/m2

    Cisplatin 50mg/m2

    Repeat every 3 weeks * 6 cycles

    Other Name: Cisplatin
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487226

Contacts
Contact: Eunkyung Park 8225125420 koreagynonco@gmail.com

Locations
Korea, Republic of
KGOG Recruiting
Seoul, Korea, Republic of
Contact: Eunkyung Park    8225125420    koreagynonco@gmail.com   
Sponsors and Collaborators
Korean Gynecologic Oncology Group
Investigators
Principal Investigator: Jong Min Lee, MD Kyung-Hee University East-West Med. Center
  More Information

No publications provided

Responsible Party: Taek Sang Lee, Principal Investigator, Korean Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01487226     History of Changes
Other Study ID Numbers: KGOG1012
Study First Received: December 4, 2011
Last Updated: December 6, 2011
Health Authority: Korean: Food and Drugs Administration

Keywords provided by Korean Gynecologic Oncology Group:
Cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasm Metastasis
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplastic Processes
Pathologic Processes
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014