Systemic Consolidation Therapy After Chemoradiation Therapy Following Operation for High Risk Early Stage Cervical Cancer

NCT ID: NCT00592059

Last Updated: 2008-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2012-11-30

Brief Summary

The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following radical hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.

Detailed Description

Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (3 cycles per 3 weeks) for high risk early stage 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.

Conditions

Cervical Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• patients who underwent radical hysterectomy for cervical cancer stage IB-IIA
• Patients who had at least one of the following risk factors in pathologic results; lymph node metastasis, positive residual resection margin, parametrial invasion
• 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 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Hospital

Principal Investigators

Jae Weon Kim, Professor

Role: STUDY_DIRECTOR

Seoul National University Hospital

Seung Su Han, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Seung Su Han, MD

Role: CONTACT

hsuu3415@snu.ac.kr

082-02-2072-2821 ext. 2821

Facility Contacts

Seung Su Han, MD

Role: primary

hsuu3415@snu.ac.kr

082-02-2072-2821 ext. 2821

Other Identifiers

Sece-1

Identifier Type: -

Identifier Source: org_study_id