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A Phase 3 Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual EBV DNA Following Radiotherapy
This study is currently recruiting participants.
Verified by Chinese University of Hong Kong, May 2008
Sponsors and Collaborators: Chinese University of Hong Kong
Hong Kong Nasopharyngeal Cancer Study Group Limited
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00370890
  Purpose

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 III

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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

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

Primary Outcome Measures:
  • Relapse free survival [ Time Frame: time from randomization to the time of first recurrence of NPC or last follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: duration from the date of randomization to the date of death due to all causes or censored at the date of last follow-up ] [ Designated as safety issue: No ]
  • Loco-regional control [ Time Frame: duration from the date of randomization to the date of first local or regional recurrence or censored at the date of last follow-up ] [ Designated as safety issue: No ]
  • Metastasis-free survival [ Time Frame: duration from the date of randomization to the date of first distant metastasis or censored at the date of last follow-up. ] [ Designated as safety issue: No ]
  • Toxicity of adjuvant chemotherapy [ Time Frame: Acute toxicities are graded according to CTC recommendation for toxicity evaluation and late toxicities are graded according to RTOG radiation morbidity scoring criteria ] [ Designated as safety issue: Yes ]
  • Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome [ Time Frame: The level of plasma EBV DNA will be correlated with PET-CT scan finding and clinical outcome in the final analysis ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2006
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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
B: No Intervention
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 or equal to 2.
  8. Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures.
  Contacts and Locations
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

Responsible Party: Trial Coordinator, Comprehensive Cancer Trials Unit ( Rosalie Ho )
Study ID Numbers: HKNPCSG 0502
Study First Received: August 30, 2006
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00370890  
Health Authority: Hong Kong: Department of Health

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

Study placed in the following topic categories:
Nasopharyngeal carcinoma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cisplatin
Head and Neck Neoplasms
Pharyngeal Neoplasms
Stomatognathic Diseases
Gemcitabine
Pharyngeal Diseases
Nasopharyngeal Neoplasms
Carcinoma

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

ClinicalTrials.gov processed this record on January 16, 2009