New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

Completed

• Conditions: Advanced Nasopharyngeal Carcinoma
• Interventions: Drug: Chemotherapy

• Registration Number: NCT01365208
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-11
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Study Start: 2011-07
• Status Verified: 2017-03
• Primary Completion: 2017-03-03
• Study Completion: 2017-03-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
advanced nasopharyngeal carcinoma	Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
progression free survival	3 Years
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
overall survival	3 Years

Trial Locations

Locations (1)

Department of Clinical Oncology, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong