Nasopharyngeal NeoplasmsNCT00563927
Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0)
A study testing Conventional RT, Cisplatin and 5-fluorouracil in people with Nasopharyngeal Neoplasms and Carcinoma, Squamous Cell, run by Hospital Authority, Hong Kong at 4 sites in China.
Trial summary
To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Nasopharyngeal Neoplasms, Carcinoma, Squamous Cell
- What is being tested?
- Conventional RT, Cisplatin and 5-fluorouracil
- Type of treatment
- Surgery or procedure
- How many people
- 340 participants
- Where
- 4 sitesChina
- Study dates
- Mar 1999to Oct 2009
- Phase
- Interventional
- 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 Up to 70 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Undifferentiated or non-keratinizing carcinoma
- Tumor staged as N2-3
- No evidence of distant metastasis M0
- Performance status:0-2
- Marrow: WBC >= 4 and platelet >= 100
- Renal: creatinine clearance >= 60
- Informed consent
Who cannot join
- WHO type I squamous cell carcinoma or adenocarcinoma
- Age >= 70
- Palliative intent or tumor extent mandating AP opposing facio-cervical fields
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
- Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume
- Previous chemotherapy
- Patient is pregnant or lactating
Trial locations and contacts
4 sites in 1 country.
China4 sites
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Queen Elizabeth Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Tuen Mun Hospital
Hong Kong
About this study
Official title: Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma
To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Neoplasms, Carcinoma, Squamous Cell
- Being tested
- Conventional RT, Cisplatin, 5-fluorouracil
- Keywords
- Nasopharyngeal Carcinoma, T1-4N2-3M0
- Medical subject headings
- Nasopharyngeal Neoplasms, Carcinoma, Squamous Cell, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RTProcedure or surgery
CisplatinDrug
5-fluorouracilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure free survival rate
Measured: 5 year
Secondary outcomes (3)
Disease-specific survival rate
Measured: 5-year
Overall survival rate
Measured: 5-year
Complication-free rates
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startMar 1999
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Hong Kong Nasopharyngeal Cancer Study Group Limited
- Investigators
- Wai Hon LAU, Dr, Principal investigator, Department of Clinical Oncology, Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563927
- Sponsor's protocol ID
- L/M-77 TO PYH08/79
- Other IDs
- HARECCTR0500023, NPC99-01
- Status last verified
- Jul 2010
- First submitted
- 21 Nov 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT00563927
- Acronym / sponsor ID
- L/M-77 TO PYH08/79
- Conditions
- Nasopharyngeal Neoplasms, Carcinoma, Squamous Cell
- Keywords
- Nasopharyngeal Carcinoma, T1-4N2-3M0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Hong Kong Nasopharyngeal Cancer Study Group Limited
- Study start
- Mar 1999
- Study completion
- Oct 2009 (estimated)
- First posted
- 26 Nov 2007 (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.
To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Undifferentiated or non-keratinizing carcinoma
- Tumor staged as N2-3
- No evidence of distant metastasis M0
- Performance status:0-2
- Marrow: WBC >= 4 and platelet >= 100
Key exclusion criteria (7 listed)
- WHO type I squamous cell carcinoma or adenocarcinoma
- Age >= 70
- Palliative intent or tumor extent mandating AP opposing facio-cervical fields
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
- Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume
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 |
|---|---|---|
| Conventional RT | Procedure or surgery | – |
| Cisplatin | Drug | – |
| 5-fluorouracil | Drug | – |
Primary outcome
Failure free survival rate
Time frame: 5 year
3 secondary outcomes
Disease-specific survival rate
Time frame: 5-year
Overall survival rate
Time frame: 5-year
Complication-free rates
Time frame: 5-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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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.
Wai Hon LAU, Dr principal investigator
Department of Clinical Oncology, Queen Elizabeth Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional RT, Cisplatin and 5-fluorouracil in people with Nasopharyngeal Neoplasms and Carcinoma, Squamous Cell, run by Hospital Authority, Hong Kong at 4 sites in China.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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.
Are results available for this study?
Results are not available in the source record.
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?
Failure free survival rate (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2010.