Nasopharyngeal CancersNCT02149641
Parotid-sparing IMRT for Nasopharyngeal Cancer
An observational study of Nasopharyngeal Cancers and Intensity Modulated Radiotherapy With Chemotherapy, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nasopharyngeal Cancers, Intensity Modulated Radiotherapy With Chemotherapy
- What is being tested?
- Intensity modulated radiotherapy with chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2006to Apr 2012
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: nasopharyngeal cancers
Who may be able to join
- nasopharyngeal cancers
Who cannot join
- Patients <16 years old or with a previous malignancy other than non-melanomatous skin cancer were excluded
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: Phase II Study of Parotid Sparing IMRT for Nasopharyngeal Cancer
In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.
Read the detailed description
The purpose of this study was to determine the feasibility in delivering induction chemotherapy and concomitant chemotherapy with IMRT in the treatment of locally advanced nasopharyngeal cancers and to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.
- Being tested
- Intensity modulated radiotherapy with chemotherapy
- 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 radiotherapy with chemotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Nasopharyngeal cancers | Intensitiy modulated radiotherapy with chemotherapy Receives: Radiation: Intensity modulated radiotherapy with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of ≥G2 xerostomia at 1 year using the subjective component LENTSOMA
Measured: 12 months
Secondary outcomes (4)
Acute radiation toxicities
Measured: 0-3 months
Late radiation toxicities
Measured: 3-24 months
loco-regional disease-free survival (LRDFS), progression-free survival (PFS) and overall survival (OS)
Measured: 2 years
chemotherapy compliance and toxicities
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startFeb 2006
- Primary completionApr 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancersStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher M Nutting, FRCR, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149641
- Sponsor's protocol ID
- CCR2608
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Parotid Sparing IMRT for Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT02149641
- Acronym / sponsor ID
- CCR2608
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 May 2014 (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.
In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.
Detailed description
The purpose of this study was to determine the feasibility in delivering induction chemotherapy and concomitant chemotherapy with IMRT in the treatment of locally advanced nasopharyngeal cancers and to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal cancers | – | Radiation: Intensity modulated radiotherapy with chemotherapyIntensitiy modulated radiotherapy with chemotherapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- nasopharyngeal cancers
Key inclusion criteria (1 listed)
- nasopharyngeal cancers
Key exclusion criteria (1 listed)
- Patients <16 years old or with a previous malignancy other than non-melanomatous skin cancer were excluded
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 radiotherapy with chemotherapy | Radiation | Nasopharyngeal cancers |
Primary outcome
the incidence of ≥G2 xerostomia at 1 year using the subjective component LENTSOMA
Time frame: 12 months
4 secondary outcomes
Acute radiation toxicities
Time frame: 0-3 months
Late radiation toxicities
Time frame: 3-24 months
loco-regional disease-free survival (LRDFS), progression-free survival (PFS) and overall survival (OS)
Time frame: 2 years
chemotherapy compliance and toxicities
Time frame: 0-12 weeks
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 29 May 2014.
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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.
Christopher M Nutting, FRCR principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Cancers and Intensity Modulated Radiotherapy With Chemotherapy, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 1 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 29 May 2014. 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 United Kingdom. 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?
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 incidence of ≥G2 xerostomia at 1 year using the subjective component LENTSOMA (time frame: 12 months). 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 29 May 2014; AzTrials last refreshed its copy on 6 Nov 2026.