Neoplasms

All Conditions

Infections

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

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Epstein-Barr Virus Infections

Virus Diseases

Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

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Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Antimetabolites

Adjuvant chemotherapy and then clinical follow-up and surveillance

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

Adjuvant chemotherapy (gemcitabine and cisplatin)

Anthony TC Chan, MD, FRCP

Roger KC Ngan, FRCR

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.

A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy

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

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

Hong Kong Nasopharyngeal Cancer Study Group Limited

Chinese University of Hong Kong

Consultant

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy	NCT00370890	Nasopharyngeal ...	Adjuvant chemot...	18 Years -	Chinese University of Hong Kong
A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy	NCT00370890	Nasopharyngeal ...	Adjuvant chemot...	18 Years -	Chinese University of Hong Kong

Spots Global Cancer Trial Database for adjuvant chemotherapy (gemcitabine and cisplatin)