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.
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Gemcitabine 1000 mg/m2 in 250 ml NS over 30 mins IV on Day 1 and 8 Cisplatin 40 mg/m2 in 1L NS over 2 h IV on Day 1 and 8 Cycle repeated every 3 weeks for total of 6 cycles
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
Relapse free survival
Time frame: 5 years
Overall survival
Overall survival is defined as the duration from the date of randomization to the date of death due to all causes or censored at the date of last follow-up
Time frame: 5 years
Loco-regional control
Time frame: 5 years
Metastasis-free survival
Time frame: 5 years
Toxicity of adjuvant chemotherapy
Time frame: 6 months
Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Department of Clinical Oncology, Tuen Mun Hospital
Hong Kong, Hong Kong
Department of Oncology, Princess Margaret Hospital
Hong Kong, Hong Kong