Spots Global Cancer Trial Database for A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy
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Trial Identification
Brief Title: A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy
Official Title: A Multi-center Prospective Randomized Phase III Trial to Determine the Benefit of Adjuvant Chemotherapy Using Gemcitabine and Cisplatin in Nasopharyngeal Carcinoma Patients With Residual EBV DNA Following Primary Radiotherapy With or Without Concurrent Cisplatin
Study ID: NCT00370890
Conditions
Interventions
Study Description
Brief Summary: The purpose of this trial is to study the benefit of adjuvant chemotherapy using gemcitabine and cisplatin in high risk NPC patients with residual EBV DNA following primary radiotherapy with or without concurrent cisplatin.
Detailed Description: * The standard treatment for nasopharynx cancer is a course of radiotherapy with or without concurrent chemotherapy. This will cure about 80% of patients. For the 20% who developed recurrence or metastases, the prognosis is poor. * Elevated EBV-DNA in plasma at end of radiotherapy has been shown to predict disease recurrence and may be a marker of subclinical residual disease. * This study aims to test whether adjuvant treatment with 6 cycles of a modern chemotherapy regimen (gemcitabine and cisplatin combination) can improve the survival of these high risk patients of nasopharynx cancer who have elevated EBV-DNA after completion of their radiotherapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong, , Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital, Hong Kong, , Hong Kong
Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong, , Hong Kong
Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, , Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong, , Hong Kong
Department of Oncology, Princess Margaret Hospital, Hong Kong, , Hong Kong
Contact Details
Name: Anthony TC Chan, MD, FRCP
Affiliation: Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong
Role: PRINCIPAL_INVESTIGATOR
Name: Roger KC Ngan, FRCR
Affiliation: Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong
Role: PRINCIPAL_INVESTIGATOR
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