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New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

This study is currently recruiting participants.
Verified April 2013 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01365208
First received: May 11, 2011
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • To determine if measuring tumor metabolic response during chemotherapy can predict survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine if measuring plasma EBV DNA (half-life) early during chemotherapy can predict survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

EBV DNA


Estimated Enrollment: 68
Study Start Date: July 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
advanced nasopharyngeal carcinoma Drug: Chemotherapy
platinum-based chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365208

Contacts
Contact: Brigette Ma, MD, FRCP 2632 1042 brigette@clo.cuhk.edu.hk
Contact: Rosalie HO, RN 2632 1135 rosalie@clo.cuhk.edu.hk

Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Brigette Ma, MD, FRCP     2632 ext 1042     brigette@clo.cuhk.edu.hk    
Contact: Rosalie HO, RN     2632 1135     rosalie@clo.cuhk.edu.hk    
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Brigette Ma, MD, FRCP Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01365208     History of Changes
Other Study ID Numbers: NPC023
Study First Received: May 11, 2011
Last Updated: April 2, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013