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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00591656
Recruitment Status : Unknown
Verified December 2007 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : January 11, 2008
Last Update Posted : January 11, 2008
Information provided by:
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 69 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Primary Chemoradiation for Locally Advanced Cervical Cancer
Study Start Date : November 2007
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00591656

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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   
Sponsors and Collaborators
Seoul National University Hospital
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Study Director: Jae Weon Kim, Professor Seoul National University Hospital
Principal Investigator: Seung Su Han, MD Seoul National University Hospital
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Responsible Party: Jae Weon Kim, Seoul National University Hospital Identifier: NCT00591656    
Other Study ID Numbers: Sece-2
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: December 2007
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases