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New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365208
First Posted: June 3, 2011
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
  Purpose
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.

Condition Intervention
Advanced Nasopharyngeal Carcinoma Drug: Chemotherapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by CCTU, Chinese University of Hong Kong:

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

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • overall survival [ Time Frame: 3 Years ]
  • progression free survival [ Time Frame: 3 Years ]

Biospecimen Retention:   Samples With DNA
EBV DNA

Enrollment: 70
Study Start Date: July 2011
Study Completion Date: March 3, 2017
Primary Completion Date: March 3, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
advanced nasopharyngeal carcinoma Drug: Chemotherapy
platinum-based chemotherapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
paitent with advanced nasopharyngeal carcinoma
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365208


Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Brigette Ma, MD, FRCP Chinese University of Hong Kong
  More Information

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01365208     History of Changes
Other Study ID Numbers: NPC023
First Submitted: May 11, 2011
First Posted: June 3, 2011
Last Update Posted: March 24, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases