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

Korean Gynecologic Oncology Group

Status and phase: Unknown; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: Cisplatin 50mg/m2; Drug: paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01487226

KGOG1012

Details and patient eligibility

About

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

Enrollment: 69 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)