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

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
paclitaxel
Cisplatin 50mg/m2
Sponsored by
Korean Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • KGOGRecruiting

Outcomes

Primary Outcome Measures

Kaplan-Meier

Secondary Outcome Measures

log-rank test Cox regression analysis

Full Information

First Posted
December 4, 2011
Last Updated
December 6, 2011
Sponsor
Korean Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT01487226
Brief Title
Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in Cervical Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean Gynecologic Oncology Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
Paclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks * 6 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin 50mg/m2
Other Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 50mg/m2 Repeat every 3 weeks * 6 cycles
Primary Outcome Measure Information:
Title
Kaplan-Meier
Secondary Outcome Measure Information:
Title
log-rank test Cox regression analysis

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eunkyung Park
Phone
8225125420
Email
koreagynonco@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Min Lee, MD
Organizational Affiliation
Kyung-Hee University East-West Med. Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
KGOG
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eunkyung Park
Phone
8225125420
Email
koreagynonco@gmail.com

12. IPD Sharing Statement

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

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