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CompletedNCT00370890Updated Feb 17, 2022

A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy

A Phase 3 interventional study of Adjuvant chemotherapy (gemcitabine and cisplatin) in Nasopharyngeal Cancer, sponsored by Chinese University of Hong Kong. Completed at 6 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-17.

Sponsored by Chinese University of Hong Kong · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this trial is to study the benefit of adjuvant chemotherapy using gemcitabine and cisplatin in high risk NPC patients with residual EBV DNA following primary radiotherapy with or without concurrent cisplatin.

Read the detailed description
  • The standard treatment for nasopharynx cancer is a course of radiotherapy with or without concurrent chemotherapy. This will cure about 80% of patients. For the 20% who developed recurrence or metastases, the prognosis is poor.
  • Elevated EBV-DNA in plasma at end of radiotherapy has been shown to predict disease recurrence and may be a marker of subclinical residual disease.
  • This study aims to test whether adjuvant treatment with 6 cycles of a modern chemotherapy regimen (gemcitabine and cisplatin combination) can improve the survival of these high risk patients of nasopharynx cancer who have elevated EBV-DNA after completion of their radiotherapy.
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Conditions studied

  • Nasopharyngeal Cancer

Keywords

  • nasopharyngeal cancer
  • adjuvant chemotherapy
  • EBV DNA
  • PET CT scan
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In context

Nasopharyngeal Carcinoma

816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.

This study's enrollment of 104 is above the median of 84 across 668 interventional studies indexed under Nasopharyngeal Carcinoma.

Browse Nasopharyngeal Carcinoma studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice.
  2. A histological diagnosis of nasopharyngeal cancer (NPC) must have been established at some time and the investigator must review and confirm the diagnosis prior to randomization.
  3. Loco-regional advanced NPC UICC/AJCC Stages IIB, III, IVA or IVB.
  4. No evidence of distant metastases in the staging work up at diagnosis.
  5. Must have detectable plasma EBV-DNA (> 0 copies/ml) at 6-8 weeks after completion of primary RT or chemo-RT
  6. No clinical evidence of persistent loco-regional disease after primary treatment
  7. Performance status of ECOG grade 0 or 1.
  8. Patients must have adequate organ and marrow function as defined below:

    leukocytes >3,000/L; absolute neutrophil count >1,500/L; platelets >100,000/L; total bilirubin \<1.5 X institutional upper limit of normal; AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal; Creatinine clearance > 50 ml/min

  9. At least 18 years of age, of either sex.
  10. If female, must be either (i) post-menopausal or surgically sterilized, or (ii) use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide for the duration of the study and must be neither pregnant nor breast-feeding.

Exclusion criteria

Exclusion Criteria:

  1. Hypercalcaemia: calcium >= 2.7 mmol/L (10.8 mg/dL).
  2. Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
  3. More that 12 weeks after completion of primary radiotherapy.
  4. Had received prior adjuvant chemotherapy.
  5. Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
  6. Have serious active infection.
  7. Patients with peripheral or ototoxicity with a grade of greater than 2.
  8. Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Experimental
    A

    Adjuvant chemotherapy and then clinical follow-up and surveillance

    Drug: Adjuvant chemotherapy (gemcitabine and cisplatin)

  • No intervention
    B

    Clinical follow-up and surveillance only

Interventions

  • DrugAdjuvant chemotherapy (gemcitabine and cisplatin)

    Gemcitabine 1000 mg/m2 in 250 ml NS over 30 mins IV on Day 1 and 8 Cisplatin 40 mg/m2 in 1L NS over 2 h IV on Day 1 and 8 Cycle repeated every 3 weeks for total of 6 cycles

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What researchers measure

Primary outcomes

  1. Relapse free survival

    Time frame: 5 years

Secondary outcomes

  1. Overall survival

    Overall survival is defined as the duration from the date of randomization to the date of death due to all causes or censored at the date of last follow-up

    Time frame: 5 years

  2. Loco-regional control

    Time frame: 5 years

  3. Metastasis-free survival

    Time frame: 5 years

  4. Toxicity of adjuvant chemotherapy

    Time frame: 6 months

  5. Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome

    Time frame: 5 years

07

Study locations

6 sites
  • Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
    Hong Kong, Hong Kong
  • Department of Clinical Oncology, Prince of Wales Hospital
    Hong Kong, Hong Kong
  • Department of Clinical Oncology, Queen Elizabeth Hospital
    Hong Kong, Hong Kong
  • Department of Clinical Oncology, Queen Mary Hospital
    Hong Kong, Hong Kong
  • Department of Clinical Oncology, Tuen Mun Hospital
    Hong Kong, Hong Kong
  • Department of Oncology, Princess Margaret Hospital
    Hong Kong, Hong Kong
08

References and documents

Publications

  • Chua ML, Chan AT. Gemcitabine: a game changer in nasopharyngeal carcinoma. Lancet. 2016 Oct 15;388(10054):1853-1854. doi: 10.1016/S0140-6736(16)31394-0. Epub 2016 Aug 23. No abstract available. PubMed 27567280 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00370890
Lead sponsor
Chinese University of Hong Kong
Collaborators
Hong Kong Nasopharyngeal Cancer Study Group Limited
Responsible party
Edwin P Hui (Consultant, Chinese University of Hong Kong) — Principal investigator
First posted
Sep 1, 2006
Start date
Sep 4, 2006
Primary completion
Oct 26, 2021
Completion
Oct 26, 2021
Last update
Feb 17, 2022

Study contacts

Anthony TC Chan, MD, FRCP
principal investigator · Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong
Roger KC Ngan, FRCR
principal investigator · Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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