Systemic Consolidation Therapy After Primary Chemoradiation Therapy for Locally Advanced 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
Recruitment status was Recruiting
Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00591656
First received: December 31, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
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Purpose
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 |
|---|
|
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 Primary Chemoradiation for Locally Advanced Cervical Cancer |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
| Estimated Enrollment: | 69 |
| 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) |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Care clinic
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591656
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: | NCT00591656 History of Changes |
| Other Study ID Numbers: | Sece-2, SECE-2 |
| Study First Received: | December 31, 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 May 22, 2013