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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01487226
• Other study ID #: KGOG1012
• Status: Recruiting
• Phase: Phase 2
• First received: December 4, 2011
• Last updated: December 6, 2011
• Start date: January 2008
• Est. completion date: January 2015

Study information

• Verified date: December 2011
• Source: Korean Gynecologic Oncology Group
• Contact: Eunkyung Park
• Phone: 8225125420
• Email: koreagynonco[@]gmail.com
• Is FDA regulated: No
• Health authority: Korean: Food and Drugs Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• paclitaxel
Paclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks * 6 cycles
• Cisplatin 50mg/m2
Cisplatin 50mg/m2 Repeat every 3 weeks * 6 cycles

Locations

Country	Name	City	State
Korea, Republic of	KGOG	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Gynecologic Oncology Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier
Secondary	log-rank test Cox regression analysis