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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Taek Sang Lee, Korean Gynecologic Oncology Group.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Taek Sang Lee, Korean Gynecologic Oncology Group Identifier:
First received: December 4, 2011
Last updated: December 6, 2011
Last verified: December 2011

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: 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 Taek Sang Lee, 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
    Drug: Cisplatin 50mg/m2

    Cisplatin 50mg/m2

    Repeat every 3 weeks * 6 cycles

    Other Name: Cisplatin

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01487226

Contact: Eunkyung Park 8225125420

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

Responsible Party: Taek Sang Lee, Principal Investigator, Korean Gynecologic Oncology Group Identifier: NCT01487226     History of Changes
Other Study ID Numbers: KGOG1012
Study First Received: December 4, 2011
Last Updated: December 6, 2011

Keywords provided by Taek Sang Lee, Korean Gynecologic Oncology Group:
Cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017