Nasopharyngeal NeoplasmsPhase 2NCT00188877
Intensity Modulated Radiation Therapy for Head and Neck Cancer
A Phase 2 study testing intensity modulated radiation therapy and cisplatinium and fluorouracil - standard treatment in people with Nasopharyngeal Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. 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?
- intensity modulated radiation therapy and cisplatinium and fluorouracil - standard treatment
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2003to Jun 2019
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma requiring primary radiation
- less than 70 yrs of age
- Stage T1-T4; N0-N3; M0
- KPS less than 70
- no prior RT to H\&N or chemotherapy for H\&N
- no other malignancy except non-melanomatous skin cancer
Show all 10Show fewer
- no distant mets
- no contraindication to RT or chemotherapy
- adequate organ function
- informed consent
Who cannot join
- Major medical or psychiatric illness, which would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Intensity Modulated Radiation Therapy for Nasopharyngeal Cancer
Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. Standard radiation treatment techniques using three or four radiation beams cannot avoid delivering some dose of radiation to these normal tissues that do not need to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of computer-controlled radiation beams aimed at your cancer to try to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells.
The doctors at Princess Margaret Hospital are conducting this study in order to test whether the use of IMRT techniques can improve the chance of controlling your cancer in the head and neck region.
- Conditions
- Nasopharyngeal Neoplasms
- Being tested
- intensity modulated radiation therapy, cisplatinium and fluorouracil - standard treatment
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensity modulated radiation therapyProcedure or surgery
cisplatinium and fluorouracil - standard treatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate 3 year local progression free survival in patients with nasopharyngeal carcinoma treated with Intensity Modulated Radiation Therapy (IMRT) techniques.
Measured: q2 monthly during year 1, q3 monthly during year 2; q4 monthly during year 3; q6 monthly during year 4 and annually thereafter
Secondary outcomes (5)
-the ability of IMRT techniques to spare long term xerostomia as evaluated by saliva flow rates.
-the nature and prevalence of acute and late side effects and their relationship to local dose.
-the dosimetric differences between conventional "forward planned" two dimensional plans, three dimensional plans and Intensity modulated radiation therapy.
-evaluation of failure with respect to the doses in the region of the failure
-quality of life measurements in patients after receiving IMRT for the treatment of nasopharyngeal carcinoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJun 2008
- Study completionJun 2019
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.
- More trials run by University Health Network, TorontoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Andrew Bayley, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188877
- Sponsor's protocol ID
- UHN REB 03-0158-C
- Status last verified
- Nov 2019
- First submitted
- 12 Sep 2005
- Last updated
- 2 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intensity Modulated Radiation Therapy for Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT00188877
- Acronym / sponsor ID
- UHN REB 03-0158-C
- Conditions
- Nasopharyngeal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Jun 2003 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 16 Sep 2005 (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.
Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. Standard radiation treatment techniques using three or four radiation beams cannot avoid delivering some dose of radiation to these normal tissues that do not need to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of computer-controlled radiation beams aimed at your cancer to try to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells.
The doctors at Princess Margaret Hospital are conducting this study in order to test whether the use of IMRT techniques can improve the chance of controlling your cancer in the head and neck region.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma requiring primary radiation
- less than 70 yrs of age
- Stage T1-T4; N0-N3; M0
- KPS less than 70
- no prior RT to H\&N or chemotherapy for H\&N
Key exclusion criteria (1 listed)
- Major medical or psychiatric illness, which would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.
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 |
|---|---|---|
| intensity modulated radiation therapy | Procedure or surgery | – |
| cisplatinium and fluorouracil - standard treatment | Drug | – |
Primary outcome
The primary objective of this study is to evaluate 3 year local progression free survival in patients with nasopharyngeal carcinoma treated with Intensity Modulated Radiation Therapy (IMRT) techniques.
Time frame: q2 monthly during year 1, q3 monthly during year 2; q4 monthly during year 3; q6 monthly during year 4 and annually thereafter
5 secondary outcomes
-the ability of IMRT techniques to spare long term xerostomia as evaluated by saliva flow rates.
-the nature and prevalence of acute and late side effects and their relationship to local dose.
-the dosimetric differences between conventional "forward planned" two dimensional plans, three dimensional plans and Intensity modulated radiation therapy.
-evaluation of failure with respect to the doses in the region of the failure
-quality of life measurements in patients after receiving IMRT for the treatment of nasopharyngeal carcinoma
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 2 Dec 2019.
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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.
Andrew Bayley, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intensity modulated radiation therapy and cisplatinium and fluorouracil - standard treatment in people with Nasopharyngeal Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
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 10 inclusion and 1 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 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary objective of this study is to evaluate 3 year local progression free survival in patients with nasopharyngeal carcinoma treated with Intensity Modulated Radiation Therapy (IMRT) techniques. (time frame: q2 monthly during year 1, q3 monthly during year 2; q4 monthly during year 3; q6 monthly during year 4 and annually thereafter). 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 2 Dec 2019.