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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 November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00591656
