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Trial Title: Systemic Consolidation Therapy After Primary Chemoradiation Therapy for Locally Advanced Cervical Cancer

NCT ID: NCT00591656

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

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.

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.

Criteria for eligibility:

Study pop:
Care clinic

Sampling method: Probability Sample
Criteria:
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

Gender: Female

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 110-744
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Seung Su Han, MD

Phone: 082-02-2072-2821

Phone ext: 2821
Email: hsuu3415@snu.ac.kr

Start date: November 2007

Completion date: November 2012

Lead sponsor:
Agency: Seoul National University Hospital
Agency class: Other

Source: Seoul National University Hospital

Record processing date: ClinicalTrials.gov processed this data on April 01, 2022

ClinicalTrials.gov page: https://clinicaltrials.gov/show/NCT00591656

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