New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2017-03-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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advanced nasopharyngeal carcinoma

Chemotherapy

Intervention Type DRUG

platinum-based chemotherapy

Interventions

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Chemotherapy

platinum-based chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No