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| Name | Class |
|---|---|
| Mackay Memorial Hospital | OTHER |
| Taichung Veterans General Hospital | OTHER |
| National Cheng-Kung University Hospital | OTHER |
| Chang Gung Memorial Hospital |
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The purpose of this study is to investigate the EBV reactivation rate in post-radiation and remission NPC patients, evaluate the safety and tolerance of EGCG and analyze the observational correlation between EBV reactivation and clinical outcome.
Patients with pathologically proven NPC, stage II-IVB and finishing curative RT ≧70 Gy within 6 months (± induction/concurrent/adjuvant chemotherapy) will be candidates for this study. Before entry, 8 CC venous blood will be obtained for EBV DNA and antibody screen tests after patient's consent. Those who have undetectable plasma EBV DNA (0 copy/ml) and fulfilled with all inclusion and exclusion criteria will be registered.
Routine re-staging work-ups after RT should show no active lesion in nasopharynx, neck and distant organs. Re-staging survey should include nasopharyngoscope, pEBV DNA assay, CBC, platelet count, renal and liver function tests, CXR, abdominal sonography or CT scan, whole body bone scan, MRI or CT scan of the head and neck region.
Within one week after finishing registration, EGCG or placebo should be started. A blood sample before taking EGCG/placebo will be collected for antibodies test and pEBV DNA assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo qd (2# bid) for 3 years |
|
| Epigallocatechin Gallate (EGCG) | Experimental | EGCG 600 mg qd (2# bid) for 3 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epigallocatechin Gallate (EGCG) | Other | EGCG 600 mg per day will be provided to the test group.Four capsules will be taken daily (2# bid) by the test individuals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EBV reactivation rates between EGCG and placebo group | Reactivation of EBV is defined as 1.Antibody against EBV VCA: The IgA antibody titers will be detected by a commercial EBV VCA ELISA kit (RE 562 71, Immuno-Biological Laboratories, Germany) Patient's serum with anti-EBV VCA greater than 10U/ml will be considered as reactivation of EBV. | every 3 months for the first 3 years and every 6 months thereafter for antibodies tests and pEBV DNA assay (total 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between EBV reactivation and OS/RFS | Observational analysis of the correlation between EBV reactivation and clinical outcome | q 3 months for first 3 years and q 6 months for the |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsang Wu Liu, MD | Taiwan Cooperative Oncology Group, National Health Research Institutes | Study Director |
| Jin Ch Lin, MD PHD | Taichung Veterans General Hospital | Principal Investigator |
| Jen Ya Chen, PHD | National Institute of Cancer Research, National Health Research Institutes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taiwan Cooperative Oncology Group, National Health Research Institutes | Zhunan | Miaoli | 350 | Taiwan |
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| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
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| OTHER |
| China Medical University Hospital | OTHER |
| National Taiwan University Hospital | OTHER |
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| Placebo | Dietary Supplement | Placebo qd (2# bid) for 3 years |
|