New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

Prospective Evaluation of Plasma EBV DNA Half-life and PET-CT Scanning as a New Tool in Assessing Early Response to Chemotherapy in Patients With Advanced Nasopharyngeal Carcinoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01365208

Enrollment

Registered

2011-06-03

Start date

2011-07-31

Completion date

2017-03-03

Last updated

2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Nasopharyngeal Carcinoma

Brief summary

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.

Interventions

DRUGChemotherapy

platinum-based chemotherapy

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Secondary

Measure	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.	3 years
overall survival	3 Years
progression free survival	3 Years

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026