New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

March 22, 2017 updated by: CCTU, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Clinical Oncology, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

paitent with advanced nasopharyngeal carcinoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
advanced nasopharyngeal carcinoma
Drug: Chemotherapy
platinum-based chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if measuring tumor metabolic response during chemotherapy can predict survival
Time Frame: 3 years
3 years
To determine if measuring plasma EBV DNA (half-life) early during chemotherapy can predict survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome 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
Time Frame: 3 years
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.
Time Frame: 3 years
3 years
overall survival
Time Frame: 3 Years
3 Years
progression free survival
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

March 3, 2017

Study Completion (Actual)

March 3, 2017

Study Registration Dates

First Submitted

May 11, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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