We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

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.
ClinicalTrials.gov Identifier: NCT01365208
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Advanced Nasopharyngeal Carcinoma Drug: Chemotherapy

Study Design

Study Type : Observational
Actual Enrollment : 70 participants
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
Study Start Date : July 2011
Primary Completion Date : March 3, 2017
Study Completion Date : March 3, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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

Secondary Outcome Measures :
  1. 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 ]
  2. 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. overall survival [ Time Frame: 3 Years ]
  4. progression free survival [ Time Frame: 3 Years ]

Biospecimen Retention:   Samples With DNA
EBV DNA

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Posted: June 3, 2011    Key Record Dates
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