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Trial of Parotid Sparing Whole Brain Radiation

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ClinicalTrials.gov Identifier: NCT03595878
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
University of Michigan
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE May 18, 2018
First Posted Date  ICMJE July 23, 2018
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE May 9, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Change from Baseline Xerostomia in Randomized Patients Post-Treatment [ Time Frame: Primary time frame of interest is baseline to 1 month post-treatment; study questionnaire administered at baseline, end of treatment (an expected average of about 10 days), and 2 weeks, 1 month, 3 months, & 6 months post-treatment ]
Proportion of randomized patients experiencing measurable acute increase in xerostomia, per symptoms reported in the study questionnaire, that is clinically significant
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03595878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Freedom from Relapse [ Time Frame: Continuously monitored throughout follow-up (an expected average of about 6 months) ]
    Time to marginal relapse and time to upper cervical spine relapse in each randomization arm
  • Change from Baseline Xerostomia in All Patients Post-Treatment Based on Treatment Fields [ Time Frame: Primary time frame of interest is baseline to 1 month post-treatment; study questionnaire administered at baseline, end of treatment (an expected average of about 10 days), and 2 weeks, 1 month, 3 months, & 6 months post-treatment ]
    Difference in proportion of all patients experiencing measurable acute increase in xerostomia that is clinically significant based on use of standard versus parotid-sparing fields
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2018)
  • Volume/Dose Relationship [ Time Frame: Primary time frame of interest is baseline to 1 month post-treatment ]
    Association between the degree of change in xerostomia score and the radiation dose received by the parotid glands
  • Change in Bothersomeness of Xerostomia [ Time Frame: Baseline to post-treatment time points - end of treatment (an expected average of about 10 days) and 2 weeks, 1 month, 3 months, & 6 months post-treatment ]
    Assessment of the change in xerostomia "bother symptoms" on the study questionnaire
  • Xerostomia Progression Timeline [ Time Frame: Primary time frame of interest is baseline to 6 months post-treatment ]
    Effect of whole brain radiation on the speed of the progression of xerostomia
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Trial of Parotid Sparing Whole Brain Radiation
Official Title  ICMJE Randomized Trial of Parotid Sparing Whole Brain Radiation
Brief Summary The purpose of this study is to evaluate the efficacy of parotid sparing in reducing measurable xerostomia (dry mouth) in patients undergoing whole brain radiotherapy. This is primarily a two-arm, single-blind, randomized study of parotid sparing whole brain radiation therapy (WBRT), with a third observational arm of patients who were identified after radiation had already started or who refused randomization but were willing to be followed for quality of life assessment. Qualifying patients who are interested in participating in the trial will be asked to complete an anonymous screening baseline xerostomia questionnaire. If their raw score on this questionnaire meets eligibility criteria, they will be offered enrollment on the study. Patients identified prior to radiation start will be offered enrollment into the interventional randomization arm, with the observation arm offered to those who refuse randomization. Patients identified after radiation has already started, but within 5 days of the first day of radiation, will be offered enrollment into the observational arm. Questionnaires completed by patients who consent to the trial will be assigned patient information (de-anonymized) and serve as their baseline quality of life data. After baseline assessment, subjects will be asked to complete the same questionnaire again at the end of treatment, as well as two weeks, one month, three months, and six months after treatment completion.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Xerostomia
Intervention  ICMJE
  • Radiation: Parotid sparing WBRT
    Whole Brain Radiation Therapy with avoidance of the parotid glands
  • Radiation: Standard WBRT
    Standard Whole Brain Radiation Therapy
Study Arms  ICMJE
  • Active Comparator: Randomized Arm - Control Group
    Patients randomized to this group will receive standard WBRT.
    Intervention: Radiation: Standard WBRT
  • Experimental: Randomized Arm - Intervention Group
    Patients randomized to this group will receive parotid sparing WBRT.
    Intervention: Radiation: Parotid sparing WBRT
  • No Intervention: Observational Arm
    Patients enrolled in this arm will be treated per their treating physician's choice.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients to be treated with WBRT using 3-dimensional conformal RT in 10-15 fractions to a total dose of 30-35 Gy for any diagnosis other than elective treatment of potentially subclinical intracranial disease.
  • No prior radiation that would have exposed the parotids to a significant level of radiation (estimated >10 Gy mean parotid dose). Patients receiving prior stereotactic radiosurgery for brain metastasis are eligible for inclusion in this trial as this form of radiation is highly conformal and exposes the parotids to minimal (estimated <1 Gy) radiation.

    • Patients enrolling on the observational arm may have started their current course of whole brain radiation therapy within 5 days prior to completing the baseline screening questionnaire and consenting to study.
  • Greater than or equal to 18 years of age (no upper age limit).
  • Raw xerostomia score < 40 / 80 on the initial screening xerostomia questionnaire. This is calculated by adding up the values from questions 1-8.
  • Initial xerostomia questionnaire and informed consent obtained within the required time frame (≤ 30 days before RT start for interventional arm; ≤ 5 days after RT start for observational arm).

Exclusion Criteria:

  • Patients receiving WBRT without the use of a CT- or MRI-based planning simulation.
  • Patients receiving WBRT with the use of intensity-modulated radiation therapy.
  • Patient receiving WBRT as elective treatment of potentially subclinical intracranial disease (e.g., WBRT for prophylactic cranial irradiation of small cell lung cancer).
  • Patients physically unable to communicate by paper or phone to complete the study survey.
  • Prisoners.
  • Pregnant patients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emily C Goldman 9849748441 emily_goldman@med.unc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03595878
Other Study ID Numbers  ICMJE LCCC 1802
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UNC Lineberger Comprehensive Cancer Center
Study Sponsor  ICMJE UNC Lineberger Comprehensive Cancer Center
Collaborators  ICMJE
  • University of North Carolina, Chapel Hill
  • University of Michigan
Investigators  ICMJE
Principal Investigator: Kyle Wang University of North Carolina at Chapel Hill, Department of Radiation Oncology
PRS Account UNC Lineberger Comprehensive Cancer Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP