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
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Cancer
Drug: Adjuvant chemotherapy (gemcitabine and cisplatin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Relapse free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: September 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Adjuvant chemotherapy and then clinical follow-up and surveillance
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
No Intervention: B
Clinical follow-up and surveillance only

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370890

Contacts
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

Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Principal Investigator: Anthony TC Chan, MD, FRCP         
Department of Clinical Oncology, Queen Elizabeth Hospital Recruiting
Hong Kong, Hong Kong
Principal Investigator: Roger KC Ngan, FRCR         
Department of Clinical Oncology, Tuen Mun Hospital Recruiting
Hong Kong, Hong Kong
Principal Investigator: Stewart Y Tung, FRCR         
Department of Clinical Oncology, Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Principal Investigator: Daniel TT Chua, FRCR         
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital Recruiting
Hong Kong, Hong Kong
Principal Investigator: T K Yau, FRCR         
Department of Oncology, Princess Margaret Hospital Recruiting
Hong Kong, Hong Kong
Principal Investigator: Ashley C Cheng, FRCR         
Sponsors and Collaborators
Chinese University of Hong Kong
Hong Kong Nasopharyngeal Cancer Study Group Limited
Investigators
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
  More Information

No publications provided

Responsible Party: Edwin P Hui, Consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00370890     History of Changes
Other Study ID Numbers: HKNPCSG 0502
Study First Received: August 30, 2006
Last Updated: June 11, 2014
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
nasopharyngeal cancer
adjuvant chemotherapy
EBV DNA
PET CT scan

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014