Clinical trial NCT01365208: New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Nasopharyngeal Carcinoma
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: paitent with 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.


Eligibility 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

Primary outcomes:
measure: To determine if measuring tumor metabolic response during chemotherapy can predict survival
timeFrame: 3 years
measure: To determine if measuring plasma EBV DNA (half-life) early during chemotherapy can predict survival
timeFrame: 3 years
Secondary outcomes:
measure: 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
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: overall survival
timeFrame: 3 Years
measure: progression free survival
timeFrame: 3 Years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Brigette Ma, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma B, Hui EP, King A, Leung SF, Kam MK, Mo F, Li L, Wang K, Loong H, Wong A, Chan CM, Chan KCA, Wong SCC, Lo YMD, Chan AT. Prospective evaluation of plasma Epstein-Barr virus DNA clearance and fluorodeoxyglucose positron emission scan in assessing early response to chemotherapy in patients with advanced or recurrent nasopharyngeal carcinoma. Br J Cancer. 2018 Apr;118(8):1051-1055. doi: 10.1038/s41416-018-0026-9. Epub 2018 Mar 20.