- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02149641
Parotid-sparing IMRT for Nasopharyngeal Cancer
May 26, 2014 updated by: Royal Marsden NHS Foundation Trust
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom, SW3 6JJ
- The Royal Marsden NHS Foundation Trust
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
nasopharyngeal cancers
Description
Inclusion Criteria:
- nasopharyngeal cancers
Exclusion Criteria:
- Patients <16 years old or with a previous malignancy other than non-melanomatous skin cancer were excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Nasopharyngeal cancers
Intensitiy modulated radiotherapy with chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the incidence of ≥G2 xerostomia at 1 year using the subjective component LENTSOMA
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acute radiation toxicities
Time Frame: 0-3 months
|
0-3 months
|
Late radiation toxicities
Time Frame: 3-24 months
|
3-24 months
|
loco-regional disease-free survival (LRDFS), progression-free survival (PFS) and overall survival (OS)
Time Frame: 2 years
|
2 years
|
chemotherapy compliance and toxicities
Time Frame: 0-12 weeks
|
0-12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
May 26, 2014
First Submitted That Met QC Criteria
May 26, 2014
First Posted (Estimate)
May 29, 2014
Study Record Updates
Last Update Posted (Estimate)
May 29, 2014
Last Update Submitted That Met QC Criteria
May 26, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
Other Study ID Numbers
- CCR2608
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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