- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487226
Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in Cervical Cancer
December 6, 2011 updated by: Taek Sang Lee, Korean Gynecologic Oncology Group
A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
69
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eunkyung Park
- Phone Number: 8225125420
- Email: koreagynonco@gmail.com
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- KGOG
-
Contact:
- Eunkyung Park
- Phone Number: 8225125420
- Email: koreagynonco@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Kaplan-Meier
|
Secondary Outcome Measures
Outcome Measure |
---|
log-rank test Cox regression analysis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jong Min Lee, MD, Kyung-Hee University East-West Med. Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Anticipated)
January 1, 2015
Study Completion (Anticipated)
January 1, 2015
Study Registration Dates
First Submitted
December 4, 2011
First Submitted That Met QC Criteria
December 6, 2011
First Posted (Estimate)
December 7, 2011
Study Record Updates
Last Update Posted (Estimate)
December 7, 2011
Last Update Submitted That Met QC Criteria
December 6, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Neoplastic Processes
- Neoplasm Metastasis
- Uterine Cervical Neoplasms
- Lymphatic Metastasis
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- KGOG1012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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