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The combination of pEBV DNA (half-life) and PET-CT following 1 course of chemotherapy allow earlier and more detection of drug response in advanced NPC than RECIST method, in patients with previously untreated advanced NPC who will receive platinum-based chemotherapy. This study will also determine if this new method can predict survival in these patients. This study may have far-reaching impact on drug development in NPC as it may offer a more optimal way of evaluating drug efficacy in clinical trials and also in clinical management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| advanced nasopharyngeal carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | platinum-based chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine if measuring tumor metabolic response during chemotherapy can predict survival | 3 years | |
| To determine if measuring plasma EBV DNA (half-life) early during chemotherapy can predict survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| New method of assessing drug response (measuring tumor metabolic response via FDG-PET & plasma EBV DNA (half-life) after 1 course of chemotherapy) can better predict survival, than the conventional method | 3 years | |
| To determine if plasma EBV DNA (half-life) correspond with best response rate based on the conventional 'Response Evaluation Criteria in Solid Tumors' - RECIST criteria. |
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Inclusion Criteria:
undergo chemotherapy for any one of the following settings:
Age >= 18 years
(ECOG) performance status of 0-2
have detectable levels of pEBV DNA at baseline
have measurable tumor sites by RECIST criteria
have adequate bone marrow, renal and hepatic functions
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paitent with advanced nasopharyngeal carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Brigette Ma, MD, FRCP | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology, Prince of Wales Hospital | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29555989 | Derived | Ma B, Hui EP, King A, Leung SF, Kam MK, Mo F, Li L, Wang K, Loong H, Wong A, Chan CM, Chan KCA, Wong SCC, Lo YMD, Chan AT. Prospective evaluation of plasma Epstein-Barr virus DNA clearance and fluorodeoxyglucose positron emission scan in assessing early response to chemotherapy in patients with advanced or recurrent nasopharyngeal carcinoma. Br J Cancer. 2018 Apr;118(8):1051-1055. doi: 10.1038/s41416-018-0026-9. Epub 2018 Mar 20. |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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EBV DNA
| 3 years |
| overall survival | 3 Years |
| progression free survival | 3 Years |