Systemic Consolidation Therapy After Chemoradiation Therapy Following Operation for High Risk Early Stage Cervical Cancer
A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Radical Hysterectomy and Adjuvant Chemoradiation for High Risk Early Stage Cervical Cancer
1 other identifier
observational
77
1 country
1
Brief Summary
The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following radical hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 28, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJanuary 11, 2008
December 1, 2007
2 years
December 28, 2007
December 31, 2007
Conditions
Eligibility Criteria
Care clinic
You may qualify if:
- patients who underwent radical hysterectomy for cervical cancer stage IB-IIA
- Patients who had at least one of the following risk factors in pathologic results; lymph node metastasis, positive residual resection margin, parametrial invasion
- 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
You may not qualify if:
- Peripheral neurotoxicity \> NCI 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jae Weon Kim, Professor
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
Seung Su Han, MD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 28, 2007
First Posted
January 11, 2008
Study Start
November 1, 2007
Primary Completion
November 1, 2009
Study Completion
November 1, 2012
Last Updated
January 11, 2008
Record last verified: 2007-12