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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00592059
First received: December 28, 2007
Last updated: December 31, 2007
Last verified: December 2007
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

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

No publications provided

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 22, 2014