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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01487226
First Posted: December 7, 2011
Last Update Posted: December 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Taek Sang Lee, Korean Gynecologic Oncology Group
  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: Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Taek Sang Lee, Principal Investigator, Korean Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01487226     History of Changes
Other Study ID Numbers: KGOG1012
First Submitted: December 4, 2011
First Posted: December 7, 2011
Last Update Posted: December 7, 2011
Last Verified: December 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
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action