Parotid-gland Stem-cell Sparing Intensity-modulated Radiotherapy (SCS-IMRT)

June 21, 2017 updated by: Roel Steenbakkers, University Medical Center Groningen

Prevention of Radiation-induced Parotid Gland Dysfunction by Parotid-gland Stem-cell Sparing Intensity-modulated Radiotherapy(SCS-IMRT)

Rationale:

Radiation-induced parotid gland dysfunction, often leading to xerostomia is the most-frequently occurring side-effect with a major impact on patient-reported quality of life after radiotherapy for head and neck cancer (HNC). Therefore, treatments for HNC are currently optimized to minimize the mean dose to the parotid glands. Though this resulted in a significant reduction of toxicity, 30%-40% of the patients still develop sustained parotid gland dysfunction and xerostomia.

However, in animal studies the investigators found that the dose to the sub-volume of the gland containing the parotid gland stem cells is a better predictor for dysfunction than the mean dose to the whole gland. Subsequently, this finding was confirmed in a retrospective analysis in patients. Therefore, a reduction of dose specifically in this sub-volume of the parotid glands of patients is expected to further reduce the risk of parotid gland dysfunction and xerostomia.

Objective:

To test the hypothesis that parotid gland stem cell sparing intensity modulated radiotherapy in HNC patients reduces the risk of parotid gland dysfunction and xerostomia as compared to conventional parotid gland sparing intensity modulated radiotherapy.

Study design:

Double-blind prospective randomized trial (51 patients per arm). Study population: Patients treated for tumours in the head-and-neck region with curative radiotherapy, with or without the addition of chemotherapy or cetuximab.

Intervention: Patients randomized into the experimental arm will receive a treatment in which the radiation dose to the parotid gland is re-distributed to minimize dose to the sub-volume containing the stem cells, while keeping the same mean dose to the parotid gland as a whole.

Main study parameters/endpoints:

Primary endpoint is parotid gland salivary secretion. Secondary endpoints are patient- and physician-rated xerostomia.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

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

      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Squamous cell carcinoma originating from the mucosa of the head and neck area or nasopharyngeal carcinoma originating from the nasopharynx;
  • The radiotherapy includes prophylactic or therapeutic irradiation of both sides of the neck (at least level II to IV);
  • Age ≥ 18 years;
  • WHO performance 0-2;
  • To reduce the uncertainty in the assessment of relative flow after treatment, pre-treatment parotid gland saliva production stimulated with 5% citric acid should exceed >0.1 ml/min

Exclusion Criteria:

  • Postoperative radiotherapy;
  • Previous radiotherapy of the head and neck region (re-irradiation);
  • Unilateral radiotherapy;
  • Primary salivary gland tumours

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard IMRT
Standard IMRT in which the mean dose to both whole parotid glands is minimized.
Experimental: Stem-cell Sparing IMRT
Stem-cell Sparing IMRT in which the mean dose to the stem cell containing region of the parotid gland is minimized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Salivary flow
Time Frame: 12 months after radiotherapy
12 months after radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient-rated Xerostomia
Time Frame: 12 months after radiotherapy
12 months after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2013

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT2011-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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