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

This study is currently recruiting participants.

Verified by Seoul National University Hospital, December 2007

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00592059

Purpose

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.

Condition
Cervical Cancer

MedlinePlus related topics: Cancer Hysterectomy

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Radical Hysterectomy and Adjuvant Chemoradiation for High Risk Early Stage Cervical Cancer

Further study details as provided by Seoul National University Hospital:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	77
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Care clinic

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592059

Contacts

Contact: Seung Su Han, MD

082-02-2072-2821 ext 2821

hsuu3415@snu.ac.kr

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Seung Su Han, MD 082-02-2072-2821 ext 2821 hsuu3415@snu.ac.kr

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Study Director:	Jae Weon Kim, Professor	Seoul National University Hospital
Principal Investigator:	Seung Su Han, MD	Seoul National University Hospital

More Information

Responsible Party:	Seoul National University Hospital ( Jae Weon Kim )
Study ID Numbers:	Sece-1
Study First Received:	December 28, 2007
Last Updated:	December 31, 2007
ClinicalTrials.gov Identifier:	NCT00592059
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Paclitaxel
Carboplatin

ClinicalTrials.gov processed this record on January 16, 2009