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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00592059
• Other study ID #: Sece-1
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2007
• Last updated: December 31, 2007
• Start date: November 2007
• Est. completion date: November 2012

Study information

• Verified date: December 2007
• Source: Seoul National University Hospital
• Contact: Seung Su Han, MD
• Phone: 082-02-2072-2821
• Email: hsuu3415[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: November 2012
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of,