Nasopharyngeal NeoplasmsNCT00577057
Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer
A study testing Conventional Radiotherapy, Accelerated Radiotherapy and Cisplatin in people with Nasopharyngeal Neoplasms, run by Hospital Authority, Hong Kong at 6 sites in China.
Trial summary
The objectives of this clinical study are threefold: 1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation. 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Neoplasms
- What is being tested?
- Conventional Radiotherapy, Accelerated Radiotherapy and Cisplatin
- Type of treatment
- Surgery or procedure
- How many people
- 798 participants
- Where
- 6 sitesChina
- Study dates
- Sep 2006to Aug 2013
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Histologically proven nasopharyngeal carcinoma
- Non-keratinizing or undifferentiated type Stage III-IVB (by AJCC/UICC 6th edition)
- Essential staging investigations: CT or MRI of nasopharyngeal region Chest x-ray (or CT thorax)
- Liver function test, alkaline phosphatase Liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated.
- Liver scan if SGOT exceeds the institutional upper limit of normal
- Adequate marrow: WBC > 4 and platelet > 100
- Adequate renal function: creatinine clearance > 60 ml/min.
- Satisfactory performance status: > 2 by ECOG System.
Who cannot join
- WHO Type I squamous cell carcinoma or adenocarcinoma
- Age > 70
- Treatment with palliative intent (including those with tumor extent mandating the use of AP opposing facio-cervical field technique)
- 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 five years.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Prince of Wales Hospital
Hong Kong
Princess Margaret Hospital
Hong Kong
Ashley Cheng, Dr
Queen Elizabeth Hospital
Hong Kong
Roger Ngan, Dr
Queen Mary Hospital
Hong Kong
Dora Kwong, Dr
Tuen Mun Hospital
Hong Kong
Stewart Y Tung, Dr
About this study
Official title: Randomized Trial to Evaluate the Therapeutic Gain by Changing the Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and the Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
The objectives of this clinical study are threefold:
- To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
- To test whether replacing fluorouracil with Xeloda in combining with cisplatin (PF or PX, respectively) in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
- To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.
- Conditions
- Nasopharyngeal Neoplasms
- Being tested
- Conventional Radiotherapy, Accelerated Radiotherapy, Cisplatin, 5-fluorouracil, Capecitabine
- Keywords
- Nasopharyngeal Carcinoma, Stage III - IVB
- Medical subject headings
- Nasopharyngeal Neoplasms, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RadiotherapyProcedure or surgery
Accelerated RadiotherapyProcedure or surgery
CisplatinDrug
5-fluorouracilDrug
CapecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 5-year
Overall Survival
Measured: 5-year
Secondary outcomes (3)
Overall / Locoregional / Distant Failure Free Rate
Measured: 5-year
Chemotherapy and RT toxicity
Measured: within 90 day from commencement of RT
Late Toxicity
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 posted19 Dec 2007 (estimated)
- Study startSep 2006
- Study completionAug 2013 (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
- Factorial
- Masking
- None (open label)
- Enrolment
- 798 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Hong Kong Nasopharyngeal Cancer Study Group Limited
- Investigators
- Anne WM Lee, Cos, Principal investigator, Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577057
- Sponsor's protocol ID
- HKEC-2006-120
- Other IDs
- HARECCTR0500062, NPC-0501
- Status last verified
- Aug 2013
- First submitted
- 18 Dec 2007
- Last updated
- 22 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Evaluate the Therapeutic Gain by Changing the Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and the Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT00577057
- Acronym / sponsor ID
- HKEC-2006-120
- Conditions
- Nasopharyngeal Neoplasms
- Keywords
- Nasopharyngeal Carcinoma, Stage III - IVB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 798 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Hong Kong Nasopharyngeal Cancer Study Group Limited
- Study start
- Sep 2006
- Study completion
- Aug 2013 (estimated)
- First posted
- 19 Dec 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.
The objectives of this clinical study are threefold:
- To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
- To test whether replacing fluorouracil with Xeloda in combining with cisplatin (PF or PX, respectively) in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
- To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven nasopharyngeal carcinoma
- Non-keratinizing or undifferentiated type Stage III-IVB (by AJCC/UICC 6th edition)
- Essential staging investigations: CT or MRI of nasopharyngeal region Chest x-ray (or CT thorax)
- Liver function test, alkaline phosphatase Liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated.
- Liver scan if SGOT exceeds the institutional upper limit of normal
Key exclusion criteria (7 listed)
- WHO Type I squamous cell carcinoma or adenocarcinoma
- Age > 70
- Treatment with palliative intent (including those with tumor extent mandating the use of AP opposing facio-cervical field technique)
- 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 five years.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
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 Radiotherapy | Procedure or surgery | – |
| Accelerated Radiotherapy | Procedure or surgery | – |
| Cisplatin | Drug | – |
| 5-fluorouracil | Drug | – |
| Capecitabine | Drug | – |
Primary outcome
Progression-free survival
Time frame: 5-year
Overall Survival
Time frame: 5-year
3 secondary outcomes
Overall / Locoregional / Distant Failure Free Rate
Time frame: 5-year
Chemotherapy and RT toxicity
Time frame: within 90 day from commencement of RT
Late Toxicity
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 22 Aug 2013.
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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.
Anne WM Lee, Cos principal investigator
Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Radiotherapy, Accelerated Radiotherapy and Cisplatin in people with Nasopharyngeal Neoplasms, run by Hospital Authority, Hong Kong at 6 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 8 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 22 Aug 2013. 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 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?
Contact Anne WM Lee, Cos ((852) 2595 4173, awmlee@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 5-year). The study lists 2 primary outcomes in all. 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 22 Aug 2013.