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Nasopharyngeal CarcinomaNCT03601390

Combining PET/CT and EBV DNA to Evaluate the Hazard of Progression in the Follow-up of Locally Advanced NPC

An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

PET/CT and EBV DNA are important in diagnosis of NPC. We consider that combining post-treament PET/CT and plasma EBV DNA may be effective in evaluating the hazard of progression in the follow-up of Locally Advanced Nasopharyngeal Carcinoma. Hence we establish this prospective cohort study. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
PET/CT and EBV DNA
Type of treatment
Medical device
How many people
387 participants
Where
1 siteChina
Study dates
1 Oct 2018to 12 Dec 2020
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: NPC patients after induction chemotherapy and concurrent chemoradiotherapy or concurrent chemoradiotherapy alone

Who may be able to join

  • Patients must be informed of the investigational nature of this study and given written informed consent.
  • Aged between 18-65, male/female.
  • Staged III or IV (AJCC 7th) NPC patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III).
  • Received induction chemotherapy and/or concurrent chemoradiotherapy.
  • ECOG scale 0-1.
  • Fertile women should practice contraception during the study period.
Show all 9Show fewer
  • HGB ≥90g/L ,WBC ≥4*109/L , PLT ≥100*109/L,
  • With normal liver function test (ALT and AST ≤2.5*ULN, TBil ≤2.0*ULN)
  • With normal renal function test (serum creatinine ≤1.5*ULN)

Who cannot join

  • Women in pregnancy or lactation
  • Prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
  • Already involved in other clinical trial.
  • Mental disorder, civil disability, limited capacity for civil conduct.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Combining Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography and Plasma EBV DNA to Evaluate the Hazard of Progression in the Follow-up of Locally Advanced Nasopharyngeal Carcinoma

PET/CT and EBV DNA are important in diagnosis of NPC. We consider that combining post-treament PET/CT and plasma EBV DNA may be effective in evaluating the hazard of progression in the follow-up of Locally Advanced Nasopharyngeal Carcinoma. Hence we establish this prospective cohort study.

Read the detailed description

Newly-diagnosed patients with stage III or IV non-metastatic Nasopharyngeal Carcinoma (AJCC 7th) will be recruited. All subjects receiving chemoradiotherapy will undergo a baseline integrated [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan or traditional follow-up examination and plasma EBV DNA test before the start of chemoradiotherapy.

Patients receiving IMRT treatment will receive a dedicated FDG PET/CT protocol 12 weeks after the end of chemoradiotherapy (primary endpoint).Plasma EBV DNA test will be performed 4, 12, 24 weeks after the end of IMRT treatment. In patients with negative PET/CT results, 2 follow-up visits are required to complement nasopharyngoscope examination and plasma EBV DNA test in the frist year. All patients will undergo annual PET/CT or traditional follow-up examination and plasma EBV DNA test 1 year after completing chemoradiation unless recurrent/residual disease is histopathologically-confirmed.

Patients with a PET/CT result suspecting for residual/recurrent/metastatic tumor must have pathological and/or clinical evidence of tumor existence before salvage therapy is started.

Being tested
PET/CT and EBV DNA
Keywords
PET/CT, EBV DNA, predicting predicting
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET/CT and EBV DNADevice

    PET/CT and EBV DNA will be proformed after the IMRT treatment

Study groups in NCT03601390
Study groupRoleWhat they receive
PET/CT and EBV DNAPatients receiving chemoradiotherapy will receive a dedicated FDG PET/CT protocol 12 weeks after the end of IMRT (primary endpoint).Plasma EBV DNA test will be performed 4, 12, 24 weeks after the end of IMRT. In patients with negative PET/CT results, 2 follow-up visits are required to complement nasopharyngoscope examination and plasma EBV DNA test in the frist year. All patients will undergo annual PET/CT or traditional follow-up examination and plasma EBV DNA test 1 year after completing chemoradiation unless recurrent/residual disease is histopathologically-confirmed.
Receives: Device: PET/CT and EBV DNA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Negative predictive value (NPV) of FDG PET/CT

    The negative predictive value (NPV) of FDG PET/CT for detecting tumor existence

    Measured: 12 weeks after IMRT treatment

Secondary outcomes (4)

  1. Negative predictive value (NPV) of EBV DNA

    Negative predictive value (NPV) of EBV DNA for detecting tumor existence

    Measured: 2-year

  2. PFS

    progression free survival after radical treatment

    Measured: 2-year

  3. Negative predictive value (NPV) of combined EBV DNA and FDG PET/CT

    Negative predictive value (NPV) of combined EBV DNA and FDG PET/CT for detecting tumor existence

    Measured: 2-year

  4. OS

    overall survival after radical treatment

    Measured: 2-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start1 Oct 2018
  3. Primary completion12 Dec 2019
  4. Study completion12 Dec 2020

Resources

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
Cohort
Time perspective
Prospective
Enrolment
387 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03601390
Sponsor's protocol ID
Post-treament PET/CT in NPC
Status last verified
Dec 2020
First submitted
18 Jul 2018
Last updated
19 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Van den Wyngaert T, Helsen N, Carp L, Hakim S, Martens MJ, Hutsebaut I, Debruyne PR, Maes ALM, van Dinther J, Van Laer CG, Hoekstra OS, De Bree R, Meersschout SAE, Lenssen O, Vermorken JB, Van den Weyngaert D, Stroobants S; ECLYPS investigators. Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography After Concurrent Chemoradiotherapy in Locally Advanced Head-and-Neck Squamous Cell Cancer: The ECLYPS Study. J Clin Oncol. 2017 Oct 20;35(30):3458-3464. doi: 10.1200/JCO.2017.73.5845. Epub 2017 Aug 30.

    PubMed 28854069

  • Marcus C, Ciarallo A, Tahari AK, Mena E, Koch W, Wahl RL, Kiess AP, Kang H, Subramaniam RM. Head and neck PET/CT: therapy response interpretation criteria (Hopkins Criteria)-interreader reliability, accuracy, and survival outcomes. J Nucl Med. 2014 Sep;55(9):1411-6. doi: 10.2967/jnumed.113.136796. Epub 2014 Jun 19.

    PubMed 24947059

  • Dibble EH, Alvarez AC, Truong MT, Mercier G, Cook EF, Subramaniam RM. 18F-FDG metabolic tumor volume and total glycolytic activity of oral cavity and oropharyngeal squamous cell cancer: adding value to clinical staging. J Nucl Med. 2012 May;53(5):709-15. doi: 10.2967/jnumed.111.099531. Epub 2012 Apr 9.

    PubMed 22492732

  • Imsande HM, Davison JM, Truong MT, Devaiah AK, Mercier GA, Ozonoff AJ, Subramaniam RM. Use of 18F-FDG PET/CT as a predictive biomarker of outcome in patients with head-and-neck non-squamous cell carcinoma. AJR Am J Roentgenol. 2011 Oct;197(4):976-80. doi: 10.2214/AJR.10.4884.

    PubMed 21940588

  • Chen QY, Guo SY, Tang LQ, Lu TY, Chen BL, Zhong QY, Zou MS, Tang QN, Chen WH, Guo SS, Liu LT, Li Y, Guo L, Mo HY, Sun R, Luo DH, Zhao C, Cao KJ, Qian CN, Guo X, Zeng MS, Mai HQ. Combination of Tumor Volume and Epstein-Barr Virus DNA Improved Prognostic Stratification of Stage II Nasopharyngeal Carcinoma in the Intensity Modulated Radiotherapy Era: A Large-Scale Cohort Study. Cancer Res Treat. 2018 Jul;50(3):861-871. doi: 10.4143/crt.2017.237. Epub 2017 Sep 13.

    PubMed 28903550

  • Chen QY, Tang QN, Tang LQ, Chen WH, Guo SS, Liu LT, Li CF, Li Y, Liang YJ, Sun XS, Guo L, Mo HY, Sun R, Luo DH, Fan YY, He Y, Chen MY, Cao KJ, Qian CN, Guo X, Mai HQ. Pretreatment Serum Amyloid A and C-reactive Protein Comparing with Epstein-Barr Virus DNA as Prognostic Indicators in Patients with Nasopharyngeal Carcinoma: A Prospective Study. Cancer Res Treat. 2018 Jul;50(3):701-711. doi: 10.4143/crt.2017.180. Epub 2017 Jul 14.

    PubMed 28707462

  • Davison JM, Ozonoff A, Imsande HM, Grillone GA, Subramaniam RM. Squamous cell carcinoma of the palatine tonsils: FDG standardized uptake value ratio as a biomarker to differentiate tonsillar carcinoma from physiologic uptake. Radiology. 2010 May;255(2):578-85. doi: 10.1148/radiol.10091479.

    PubMed 20413767

  • Paidpally V, Tahari AK, Lam S, Alluri K, Marur S, Koch W, Wahl RL, Subramaniam RM. Addition of 18F-FDG PET/CT to clinical assessment predicts overall survival in HNSCC: a retrospective analysis with follow-up for 12 years. J Nucl Med. 2013 Dec;54(12):2039-45. doi: 10.2967/jnumed.113.121285. Epub 2013 Oct 7.

    PubMed 24101687

  • Sherriff JM, Ogunremi B, Colley S, Sanghera P, Hartley A. The role of positron emission tomography/CT imaging in head and neck cancer patients after radical chemoradiotherapy. Br J Radiol. 2012 Nov;85(1019):e1120-6. doi: 10.1259/bjr/20976707. Epub 2012 Jun 27.

    PubMed 22744325

  • Wong RJ. Current status of FDG-PET for head and neck cancer. J Surg Oncol. 2008 Jun 15;97(8):649-52. doi: 10.1002/jso.21018.

    PubMed 18493944

Questions about this trial

What is this clinical trial studying?

An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

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 5 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 19 Dec 2020. 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 China. 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?

Negative predictive value (NPV) of FDG PET/CT (time frame: 12 weeks after IMRT treatment). 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 NCT03601390, which also lists 10 linked publications.

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 19 Dec 2020.

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