Status:
COMPLETED
Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer
Lead Sponsor:
Korea Cancer Center Hospital
Conditions:
CERVICAL NEOPLASMS
Eligibility:
FEMALE
20-75 years
Phase:
PHASE2
Brief Summary
Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical cancer. However, the most effective chemotherapy regimen is controversial. Weekly cisplatin, hydroxyurea + cispl...
Detailed Description
Cervical carcinoma is one of the most common gynecologic cancers worldwide. The prognosis of cervical cancer is favorable, with an approximately 80-90% 5-year survival rate in early-stage disease. How...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically confirmed cervical cancer
- Clinical stage from 2b to 4a
- Equal to or younger than 75
- Gog performance status 0 - 2
- Anc \> 1500/mm3 and platelet \> 100000/mm3 and hemoglobin \> 10 g/dl
- Serum creatinine \< 2.0
- AST, ALT \< 3 \* upper normal level and serum bilirubin \< 1.5 mg/dl
- Expected survival equal to or longer than 6 months
- Who agreed to participate in this study
- Exclusion criteria:
- History of chemotherapy or radiation to abdomen or pelvis
- History of other cancers
- Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2
- History of allergy or hypersensitivity reaction to platinum
- History of atrial or ventricular arrhythmia, or congestive heart failure
- Uncontrolled diabetes, hypertension, or ischemic heart disease
- Myocardial infarction within 6 months
- Sepsis or severe infection
- Pregnant women
- An unapproved therapy within 30 days before enrollment
- Other serious diseases which can threat the safety of participants or impair the ability of participants to participate this trial
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00916500
Start Date
March 1 2006
End Date
December 1 2013
Last Update
May 1 2014
Active Locations (1)
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1
Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences
Seoul, South Korea, 139-706