CERVICAL NEOPLASMS Clinical Trial
Official title:
A Phase II Trial of Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer Patients
Verified date | April 2014 |
Source | Korea Cancer Center Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical
cancer.
However, the most effective chemotherapy regimen is controversial. Weekly cisplatin,
hydroxyurea + cisplatin, 5-FU + cisplatin are tested in clinical trials.
Weekly cisplatin needs frequent hospital visits and had a poor compliance profile in korea.
Combination chemotherapy regimens had more adverse effects than weekly cisplatin without
improving outcomes.
We conducted a retrospective analysis comparing weekly cisplatin with cisplatin every 3
weeks and observed favorable outcome for cisplatin every 3 weeks regimen (still not
published).
Therefore, we designed a phase 2 trial evaluating the efficacy and feasibility of CCRT with
cisplatin every 3 weeks.
Status | Completed |
Enrollment | 71 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion criteria: 1. Histologically confirmed cervical cancer 2. Clinical stage from 2b to 4a 3. Equal to or younger than 75 4. Gog performance status 0 - 2 5. Anc > 1500/mm3 and platelet > 100000/mm3 and hemoglobin > 10 g/dl 6. Serum creatinine < 2.0 7. AST, ALT < 3 * upper normal level and serum bilirubin < 1.5 mg/dl 8. Expected survival equal to or longer than 6 months 9. Who agreed to participate in this study Exclusion criteria: 1. History of chemotherapy or radiation to abdomen or pelvis 2. History of other cancers 3. Pleural or pericardial effusion, ascites causing respiratory difficulties equal to or worse than NCI CTCAE grade 2 4. History of allergy or hypersensitivity reaction to platinum 5. History of atrial or ventricular arrhythmia, or congestive heart failure 6. Uncontrolled diabetes, hypertension, or ischemic heart disease 7. Myocardial infarction within 6 months 8. Sepsis or severe infection 9. Pregnant women 10. An unapproved therapy within 30 days before enrollment 11. Other serious diseases which can threat the safety of participants or impair the ability of participants to participate this trial |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea Cancer Center Hospital, Korea Institute of Radiological & Medical Sciences | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea Cancer Center Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DISEASE-FREE SURVIVAL | 5 YEAR AFTER THERAPY | No | |
Secondary | DISEASE-FREE SURVIVAL | 2 YEAR AFTER THERAPY | No | |
Secondary | OVERALL SURVIVAL | FROM THERAPY TO DEATH | No | |
Secondary | RECURRENCE RATE | 2 YEAR AFTER THERAPY | No | |
Secondary | RECURRENCE RATE | 5 YEAR AFTER THERAPY | No |
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