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

Conditions

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

  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust

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
Radiation: Intensity 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.

Sponsor

Royal Marsden NHS Foundation Trust

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

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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