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Completed

NCT Number: NCT01365208

New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

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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Key information

Conditions

Advanced Nasopharyngeal Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Chemotherapy

Drug

platinum-based chemotherapy

Primary outcomes

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

    Time frame: 3 years

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

    Time frame: 3 years

Secondary outcomes

  1. 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

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

  3. overall survival

    Time frame: 3 Years

  4. progression free survival

    Time frame: 3 Years

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2011
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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