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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Chinese University of Hong Kong
Sponsor:
Collaborator:
Hong Kong Nasopharyngeal Cancer Study Group Limited
Information provided by (Responsible Party):
Edwin P Hui, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00370890
First received: August 30, 2006
Last updated: June 11, 2014
Last verified: June 2014

August 30, 2006
June 11, 2014
September 2006
December 2014   (final data collection date for primary outcome measure)
Relapse free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Relapse free survival
Complete list of historical versions of study NCT00370890 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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
  • Loco-regional control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Metastasis-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Toxicity of adjuvant chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival
  • Loco-regional control
  • Metastasis-free survival
  • Toxicity of adjuvant chemotherapy
  • Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome
Not Provided
Not Provided
 
A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy
A Multi-center Prospective Randomized Phase III Trial to Determine the Benefit of Adjuvant Chemotherapy Using Gemcitabine and Cisplatin in Nasopharyngeal Carcinoma Patients With Residual EBV DNA Following Primary Radiotherapy With or Without Concurrent Cisplatin

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.

  • 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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasopharyngeal Cancer
Drug: Adjuvant 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
  • Experimental: A
    Adjuvant chemotherapy and then clinical follow-up and surveillance
    Intervention: Drug: Adjuvant chemotherapy (gemcitabine and cisplatin)
  • No Intervention: B
    Clinical follow-up and surveillance only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2014
December 2014   (final data collection date for primary outcome measure)

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:

  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.
Both
18 Years and older
No
Contact: Anthony TC Chan, MD, FRCP (852) 2632 2119 anthonytcchan@cuhk.edu.hk
Contact: Rosalie Ho, RN (852) 2632 1135 rosalie@clo.cuhk.edu.hk
Hong Kong
 
NCT00370890
HKNPCSG 0502
Yes
Edwin P Hui, Chinese University of Hong Kong
Chinese University of Hong Kong
Hong Kong Nasopharyngeal Cancer Study Group Limited
Principal Investigator: Anthony TC Chan, MD, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong
Principal Investigator: Roger KC Ngan, FRCR Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong
Chinese University of Hong Kong
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP