A Phase III Trial in NPC With Post-radiation Detectable Plasma EBV DNA

NCT02363400 | Terminated Phase 3 DMC

• 1 other identifier: T1313
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 6

Brief Summary

Nasopharyngeal carcinoma (NPC) is a geographically endemic, Epstein-Barr virus (EBV)-associated carcinoma of epidermoid origin. It occurs most commonly in Southern China and Southeast Asia. The NPC cells are poorly differentiated or undifferentiated with a high incidence of lymphatic and hematological dissemination. Because of the inherent anatomic constraints and a high degree of radiosensitivity, radiotherapy (RT) has been the primary treatment for NPC patients. NPC is also a chemosensitive tumor. Various modes of combined chemoradiotherapy have been used to treat NPC patients with advanced-stage diseases during recent 20 years. However, treatment outcome for locoregionally advanced NPC is still unsatisfactory.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma (NPC); Epstein-Barr virus (EBV); radiotherapy (RT); Plasma EBV DNA(pEBV DNA); Adjuvant Chemotherapy; PET-CT scan at Pre-Tx restaging

Outcome Measures

Primary Outcomes (1)

• Time to progression

  5 years

Secondary Outcomes (4)

• Progression-free survival and relapse rate

  5 years

• Overall survival

  5 years

• Toxicity profile and tolerance, according to CTCAE 4.1

  5 years

• Predicting value of plasma EBV DNA

  5 years

Study Arms (2)

Adjuvant Chemotherapy

EXPERIMENTAL

MEP followed by oral Tegafur-uracil

Drug: MEP

control arm

NO INTERVENTION

closely followed with frequency similar to the experiemental arm

Interventions

MEP DRUG

Adjuvant Chemotherapy

Also known as: epirubicin, cisplatin, oral Tegafur-uracil, mitomycin-C

Adjuvant Chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological proven NPC.
• AJCC stage II-IVB.
• Age ≧ 20 years old.
• Performance status of ECOG ≦ 2.
• Finished RT ≧ 66 Gy (± induction and/or concurrent chemotherapy).
• pEBV DNA \> 0 copy/ml at 1±1 week post-RT.
• Re-staging work-ups at 10±2 weeks post-RT showing no active lesions.
• Adequate liver, renal, and bone marrow function 4 weeks before randomization.
• Signed informed consent.

You may not qualify if:

• Pathologically-proven the presence of locoregional disease and/or distant metastasis.
• Unequivocally-shown active NPC (locoregional/distant) by imaging studies.
• Inadequate RT.
• Received any post-RT adjuvant chemotherapy.
• pEBV DNA = 0 copy/ml at 1±1 week post-RT.
• Previous delivery of cisplatin dose \> 600 mg/m2.
• Previous delivery of epirubicin \> 360 mg/m2.
• History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of breast.
• Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
• Female patients who are pregnant or lactating.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Mackay Memorial Hospital: collaborator
• China Medical University Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Kaohsiung Veterans General Hospital.: collaborator
• Taichung Veterans General Hospital: collaborator
• Koo Foundation Sun Yat-Sen Cancer Center: collaborator

Study Sites (6)

Kaohsiung Veterans General Hospital.

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

National Cheng-Kung University Hospital

Tainan, Taiwan

Location

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

Sun Yat-sen University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Epstein-Barr Virus Infections

Interventions

Epirubicin; Cisplatin; Tegafur; Mitomycin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Mitomycins; Indolequinones; Quinones; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jin-Ching Lin, MD, PHD

  Taichung Veterans General Hospital

  STUDY CHAIR

• Tsang-Wu Liu, MD

  National Health Research Institutes, Taiwan

  STUDY DIRECTOR

• Jin-Ching Lin, MD, PhD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

• Yi-Fang Chang, MD, PhD

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Ching-Yun Hsieh, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Chia-Jui Yen Yen, MD. PhD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

• Yaoh-Shiang Lin, MD

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

• Stella Yu-Chen Tsai, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Hsiao-Hui Tsou, PhD

  National Health Research Institutes, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: February 16, 2015
• Study Start: December 14, 2014
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 19, 2025

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)