New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

Advanced Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365208
• Other study ID #: NPC023
• Status: Completed
• Phase: N/A
• First received: May 11, 2011
• Last updated: March 22, 2017
• Start date: July 2011
• Est. completion date: March 3, 2017

Study information

• Verified date: March 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 3, 2017
• Est. primary completion date: March 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Nasopharyngeal Carcinoma
• Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Chemotherapy
platinum-based chemotherapy

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if measuring tumor metabolic response during chemotherapy can predict survival		3 years
Primary	To determine if measuring plasma EBV DNA (half-life) early during chemotherapy can predict survival		3 years
Secondary	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
Secondary	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
Secondary	overall survival		3 Years
Secondary	progression free survival		3 Years