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

A Phase II Trial of Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in FIGO Stage IA2-IIA Cervical Cancer

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01487226
Enrollment
69
Registered
2011-12-07
Start date
2008-01-31
Completion date
2015-01-31
Last updated
2011-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Cervical cancer

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

Interventions

DRUGpaclitaxel

Paclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks \* 6 cycles

DRUGCisplatin 50mg/m2

Cisplatin 50mg/m2 Repeat every 3 weeks \* 6 cycles

Sponsors

Korean Gynecologic Oncology Group
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Kaplan-Meier

Secondary

MeasureTime frame
log-rank test Cox regression analysis

Countries

South Korea

Contacts

Primary ContactEunkyung Park
koreagynonco@gmail.com8225125420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026