New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

The Chinese University of Hong Kong

Status: Completed

Conditions: Advanced Nasopharyngeal Carcinoma

Treatments: Drug: Chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT01365208

NPC023

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• undergo chemotherapy for any one of the following settings:

  1. Setting 1: Neoadjuvant chemotherapy prior to cheom-RT
  2. Setting 2: Palliative chemotherapy in Chemonaive patients
  3. Setting 3: Palliative chemotherapy in previously treated patients (i.e. 2nd line or 3rd line chemo)

• 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

Trial design

70 participants in 1 patient group

advanced nasopharyngeal carcinoma

Treatment:

Drug: Chemotherapy