New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

NCT01365208 | Completed

• 1 other identifier: NPC023
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (2)

• To determine if measuring tumor metabolic response during chemotherapy can predict survival

  3 years

• To determine if measuring plasma EBV DNA (half-life) early during chemotherapy can predict survival

  3 years

Secondary Outcomes (4)

• 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

  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.

  3 years

• overall survival

  3 Years

• progression free survival

  3 Years

Study Arms (1)

advanced nasopharyngeal carcinoma

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

platinum-based chemotherapy

advanced nasopharyngeal carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

paitent with advanced nasopharyngeal carcinoma

You may qualify if:

• undergo chemotherapy for any one of the following settings:
• Setting 1: Neoadjuvant chemotherapy prior to cheom-RT
• Setting 2: Palliative chemotherapy in Chemonaive patients
• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 29555989 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EBV DNA

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Brigette Ma, MD, FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comprehensive Clinical Trial Unit

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: June 3, 2011
• Study Start: July 1, 2011
• Primary Completion: March 3, 2017
• Study Completion: March 3, 2017
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

HK (1)