Nasopharyngeal CancerPhase 3NCT00370890
A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy
A Phase 3 study testing Adjuvant chemotherapy (gemcitabine and cisplatin) in people with Nasopharyngeal Cancer, run by Chinese University of Hong Kong at 6 sites in Hong Kong.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Cancer
- What is being tested?
- Adjuvant chemotherapy (gemcitabine and cisplatin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 6 sitesHong Kong
- Study dates
- 4 Sep 2006to 26 Oct 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice.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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Hong Kong6 sites
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
Department of Clinical Oncology, Queen Elizabeth Hospital
Hong Kong
Department of Clinical Oncology, Queen Mary Hospital
Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
Hong Kong
Department of Oncology, Princess Margaret Hospital
Hong Kong
About this 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
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.
- Conditions
- Nasopharyngeal Cancer
- Being tested
- Adjuvant chemotherapy (gemcitabine and cisplatin)
- Keywords
- nasopharyngeal cancer, adjuvant chemotherapy, EBV DNA, PET CT scan
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemotherapy (gemcitabine and cisplatin)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Adjuvant chemotherapy and then clinical follow-up and surveillance Receives: Drug: Adjuvant chemotherapy (gemcitabine and cisplatin) |
| B | No intervention | Clinical follow-up and surveillance only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival
Measured: 5 years
Secondary outcomes (5)
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
Measured: 5 years
Loco-regional control
Measured: 5 years
Metastasis-free survival
Measured: 5 years
Toxicity of adjuvant chemotherapy
Measured: 6 months
Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study start4 Sep 2006
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Nasopharyngeal Cancer Study Group Limited
- Responsible party
- Principal investigator, Edwin P Hui, Chinese University of Hong Kong
- Investigators
- Anthony TC Chan, MD, FRCP, Principal investigator, Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong KongRoger KC Ngan, FRCR, Principal investigator, Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370890
- Sponsor's protocol ID
- HKNPCSG 0502
- Status last verified
- Feb 2022
- First submitted
- 30 Aug 2006
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00370890
- Acronym / sponsor ID
- HKNPCSG 0502
- Conditions
- Nasopharyngeal Cancer
- Keywords
- nasopharyngeal cancer, adjuvant chemotherapy, EBV DNA, PET CT scan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Nasopharyngeal Cancer Study Group Limited
- Study start
- 4 Sep 2006 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 1 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Adjuvant chemotherapy (gemcitabine and cisplatin)Adjuvant chemotherapy and then clinical follow-up and surveillance |
| B | No intervention | –Clinical follow-up and surveillance only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | A |
Primary outcome
Relapse free survival
Time frame: 5 years
5 secondary outcomes
Overall survival
Time frame: 5 years
Loco-regional control
Time frame: 5 years
Metastasis-free survival
Time frame: 5 years
Toxicity of adjuvant chemotherapy
Time frame: 6 months
Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Derived from this study: PubMed 27567280Chua 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant chemotherapy (gemcitabine and cisplatin) in people with Nasopharyngeal Cancer, run by Chinese University of Hong Kong at 6 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00370890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.