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

NCT ID: NCT00591656

Last Updated: 2008-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervical Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Jae Weon Kim, Professor

Role: STUDY_DIRECTOR

Seoul National University Hospital

Seung Su Han, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Seung Su Han, MD

Role: primary

082-02-2072-2821 ext. 2821

Other Identifiers

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SECE-2

Identifier Type: -

Identifier Source: secondary_id

Sece-2

Identifier Type: -

Identifier Source: org_study_id

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