Advanced Nasopharyngeal CarcinomaNCT01365208
New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer
An observational study of Advanced Nasopharyngeal Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Nasopharyngeal Carcinoma
- What is being tested?
- Chemotherapy
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2011to 3 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: paitent with advanced nasopharyngeal carcinoma
Who may be able to join
- 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
Show all 9Show fewer
- have detectable levels of pEBV DNA at baseline
- have measurable tumor sites by RECIST criteria
- have adequate bone marrow, renal and hepatic functions
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
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
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
- Being tested
- Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
platinum-based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| advanced nasopharyngeal carcinoma | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if measuring tumor metabolic response during chemotherapy can predict survival
Measured: 3 years
To determine if measuring plasma EBV DNA (half-life) early during chemotherapy can predict survival
Measured: 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
Measured: 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.
Measured: 3 years
overall survival
Measured: 3 Years
progression free survival
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJul 2011
- Primary completion3 Mar 2017
- Study completion3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Brigette Ma, MD, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365208
- Sponsor's protocol ID
- NPC023
- Status last verified
- Mar 2017
- First submitted
- 11 May 2011
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29555989
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01365208
- Acronym / sponsor ID
- NPC023
- Conditions
- Advanced Nasopharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| advanced nasopharyngeal carcinoma | – | Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- paitent with advanced nasopharyngeal carcinoma
Key inclusion criteria (9 listed)
- undergo chemotherapy for any one of the following settings:
- Age >= 18 years
- (ECOG) performance status of 0-2
- have detectable levels of pEBV DNA at baseline
- have measurable tumor sites by RECIST criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapyplatinum-based chemotherapy | Drug | advanced nasopharyngeal carcinoma |
Primary outcome
To determine if measuring tumor metabolic response during chemotherapy can predict survival
Time frame: 3 years
To determine if measuring plasma EBV DNA (half-life) early during chemotherapy can predict survival
Time frame: 3 years
4 secondary outcomes
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
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
overall survival
Time frame: 3 Years
progression free survival
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Derived from this study: PubMed 29555989Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigette Ma, MD, FRCP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Nasopharyngeal Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if measuring tumor metabolic response during chemotherapy can predict survival (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01365208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.