Systemic Consolidation Therapy After Primary Chemoradiation Therapy for Locally Advanced Cervical Cancer

• Conditions: Cervical Cancer

• Registration Number: NCT00591656
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following primary chemoradiation for locally advanced cervical cancer.

Detailed Description

Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following primary chemoradiation (3 cycles per 3 weeks) for locally advanced cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.

Study Timeline

• Study Start: 2007-11
• Status Verified: 2007-12
• Study First Submitted: 2007-12-31
• Study First Submitted QC: 2007-12-31
• Last Update Submitted: 2007-12-31
• Study First Posted: 2008-01-11
• Last Update Posted: 2008-01-11
• Primary Completion: 2009-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

• patients who underwent three cycles of concurrent chemoradiation therapy with paclitaxel and carboplatin for non-small cell type cervical cancer stage IB2, bulky size (>4cm) IIA,IIB-IVA
• above 20 years
• GOG performance status 0-2
• Informed consent
• Platelet>100K, Hb> 10.0 g/dl, ANC>1500/mm3, Cr <1.25*upper normal limit, bilirubin<1.5mg/dl, AST & ALT<*3 upper normal limit
• Expected life > 6 months

Exclusion Criteria

• Peripheral neurotoxicity > NCI CTCAE grade 2
• Sever infection
• Previous history with chemotherapy or radiation therapy
• Pleural effusion, pericardial effusion, and ascites which could cause dyspnea > NCI grade 2
• Paraaortic lymph node metastasis
• Allergy with platinum
• Previous history of atrial or ventricular arrhythmia or congestive heart failure
• Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months
• Severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of