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

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Device: PET/CT and EBV DNA

• Registration Number: NCT03601390
• Lead Sponsor: Sun Yat-sen University

Brief 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.

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.

Study Timeline

• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-26
• Study Start: 2018-10-01
• Primary Completion: 2019-12-12
• Status Verified: 2020-12
• Study Completion: 2020-12-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

Inclusion Criteria

• 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.
• 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)

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PET/CT and EBV DNA	PET/CT and EBV DNA	Patients 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.

Primary Outcome Measures

Name	Time	Method
Negative predictive value (NPV) of FDG PET/CT	12 weeks after IMRT treatment	The negative predictive value (NPV) of FDG PET/CT for detecting tumor existence

Secondary Outcome Measures

Name	Time	Method
Negative predictive value (NPV) of EBV DNA	2-year	Negative predictive value (NPV) of EBV DNA for detecting tumor existence
PFS	2-year	progression free survival after radical treatment
Negative predictive value (NPV) of combined EBV DNA and FDG PET/CT	2-year	Negative predictive value (NPV) of combined EBV DNA and FDG PET/CT for detecting tumor existence
OS	2-year	overall survival after radical treatment

Trial Locations

Locations (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China