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Nasopharyngeal CarcinomaPhase 3NCT02363400

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

A Phase 3 study testing MEP in people with Nasopharyngeal Carcinoma, run by National Health Research Institutes, Taiwan at 6 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
MEP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
6 sitesTaiwan
Study dates
14 Dec 2014to 31 Dec 2021
Phase
Phase 3
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Histological proven NPC.
  • 2.2010 AJCC stage II-IVB.
  • 3.Age ≧ 20 years old.
  • 4.Performance status of ECOG ≦ 2.
  • 5.Finished RT ≧ 66 Gy (± induction and/or concurrent chemotherapy).
  • 6.pEBV DNA > 0 copy/ml at 1±1 week post-RT.
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  • 7.Re-staging work-ups at 10±2 weeks post-RT showing no active lesions.
  • 8.Adequate liver, renal, and bone marrow function 4 weeks before randomization.
  • 9.Signed informed consent.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Taiwan6 sites

  • Kaohsiung Veterans General Hospital.

    Kaohsiung City

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng-Kung University Hospital

    Tainan

  • Mackay Memorial Hospital

    Taipei, 104

  • Sun Yat-sen University

    Taipei

Other trials in Taiwan

About this study

Official title: Phase III Randomized Trial of Immediate Adjuvant Chemotherapy or Delayed Salvage Chemotherapy in Nasopharyngeal Carcinoma Patients With Post-radiation Detectable Plasma EBV DNA

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.

Read the detailed description

The current NCCN guidelines recommend that CCRT + adjuvant chemotherapy for advanced (stage III-IV) NPC, originated from the results of the Intergroup study [69]. However, all meta-analysis reported no any benefit in using adjuvant chemotherapy for NPC patients [82-85]. These contradictions puzzle most oncologists for decades. In our opinion, routine delivery of post-radiation adjuvant chemotherapy after RT±induction/concurrent chemotherapy for "all" advanced-stage NPC patients should be re-considered. The major goal of adjuvant chemotherapy in NPC is to reduce the occurrences of distant failure. But, not all advanced NPC patients need adjuvant chemotherapy. In our previous phase III study, only 19.1% (27/141) NPC patients with 1988 AJCC stage III-IV disease developed distant failure after CCRT . In another study of 210 NPC patients with 1997 AJCC stage IIB-IVB treated by induction chemotherapy + RT, 55 patients (26.2%) suffered from subsequent distant metastasis [67]. We should remember that unnecessary adjuvant therapy is frequently used. For example, if the target patients have as high as 50% subsequent distant failure rate, and the adjuvant therapy protocol has a 50% control rate for the subclinical disease. When we treat all target patients, only 25% patients benefit from the adjuvant therapy because of unnecessary treatment in 50% and ineffective treatment in another 25% patients. Thus, adjuvant therapy should be designed for "selected" patients. For NPC patients, pEBV DNA-guided adjuvant therapy trial is very reasonable. We plan to prove that adjuvant chemotherapy is beneficial for post-radiation detectable pEBV DNA patients in this prospective multi-center trial. We will conduct another trial to investigate (compare) which adjuvant chemotherapy regimen is the best one in the future.

Being tested
MEP
Keywords
Nasopharyngeal carcinoma (NPC), Epstein-Barr virus (EBV), radiotherapy (RT), Plasma EBV DNA(pEBV DNA), Adjuvant Chemotherapy, PET-CT scan at Pre-Tx restaging
Medical subject headings
Nasopharyngeal Carcinoma, Epstein-Barr Virus Infections

What participants receive

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

  • MEPDrug

    Also called epirubicin, cisplatin, oral Tegafur-uracil, mitomycin-C

    Adjuvant Chemotherapy

Study groups in NCT02363400
Study groupRoleWhat they receive
Adjuvant ChemotherapyExperimentalMEP followed by oral Tegafur-uracil
Receives: Drug: MEP
control armNo interventionclosely followed with frequency similar to the experiemental arm

What is being measured

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

  1. Time to progression

    Measured: 5 years

Secondary outcomes (4)

  1. Progression-free survival and relapse rate

    Measured: 5 years

  2. Overall survival

    Measured: 5 years

  3. Toxicity profile and tolerance, according to CTCAE 4.1

    Measured: 5 years

  4. Predicting value of plasma EBV DNA

    Measured: 5 years

Timeline

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

  1. First posted16 Feb 2015 (estimated)
  2. Study start14 Dec 2014
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Why it stopped: Recruiting progress behind expectation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02363400
Sponsor's protocol ID
T1313
Status last verified
Dec 2016
First submitted
4 Dec 2014
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MEP in people with Nasopharyngeal Carcinoma, run by National Health Research Institutes, Taiwan at 6 sites in Taiwan.

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 10 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: stopped early, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Taiwan. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruiting progress behind expectation). Results are not available in the source record.

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?

Time to progression (time frame: 5 years). 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 NCT02363400.

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 Aug 2025.

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