- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00370890
A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy
February 15, 2022 updated by: Edwin P Hui, Chinese University of Hong Kong
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hong Kong, Hong Kong
- Department of Clinical Oncology, Queen Mary Hospital
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Hong Kong, Hong Kong
- Department of Clinical Oncology, Prince of Wales Hospital
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Hong Kong, Hong Kong
- Department of Clinical Oncology, Tuen Mun Hospital
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Hong Kong, Hong Kong
- Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
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Hong Kong, Hong Kong
- Department of Clinical Oncology, Queen Elizabeth Hospital
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Hong Kong, Hong Kong
- Department of Oncology, Princess Margaret Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice.
- 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.
- Loco-regional advanced NPC UICC/AJCC Stages IIB, III, IVA or IVB.
- No evidence of distant metastases in the staging work up at diagnosis.
- Must have detectable plasma EBV-DNA (> 0 copies/ml) at 6-8 weeks after completion of primary RT or chemo-RT
- No clinical evidence of persistent loco-regional disease after primary treatment
- Performance status of ECOG grade 0 or 1.
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
- At least 18 years of age, of either sex.
- 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:
- Hypercalcaemia: calcium >= 2.7 mmol/L (10.8 mg/dL).
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
- More that 12 weeks after completion of primary radiotherapy.
- Had received prior adjuvant chemotherapy.
- Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- Have serious active infection.
- Patients with peripheral or ototoxicity with a grade of greater than 2.
- Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Adjuvant chemotherapy and then clinical follow-up and surveillance
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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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No Intervention: B
Clinical follow-up and surveillance only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse free survival
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 5 years
|
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
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5 years
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Loco-regional control
Time Frame: 5 years
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5 years
|
|
Metastasis-free survival
Time Frame: 5 years
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5 years
|
|
Toxicity of adjuvant chemotherapy
Time Frame: 6 months
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6 months
|
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Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome
Time Frame: 5 years
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 4, 2006
Primary Completion (Actual)
October 26, 2021
Study Completion (Actual)
October 26, 2021
Study Registration Dates
First Submitted
August 30, 2006
First Submitted That Met QC Criteria
August 30, 2006
First Posted (Estimate)
September 1, 2006
Study Record Updates
Last Update Posted (Actual)
February 17, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Cisplatin
Other Study ID Numbers
- HKNPCSG 0502
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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