Trial of Parotid Sparing Whole Brain Radiation

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Colette Shen

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Colette Shen

Principal Investigator

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Eligibility Criteria

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.

Treatment Details

Interventions

• Parotid sparing WBRT (Radiation)
• Standard WBRT (Radiation)

Participant Groups

Group I: Randomized Arm - Intervention Group Experimental Treatment 1 Intervention

Patients randomized to this group will receive parotid sparing WBRT.

Group II: Randomized Arm - Control Group Active Control 1 Intervention

Patients randomized to this group will receive standard WBRT.

Group III: Observational Arm Active Control 1 Intervention

Patients enrolled in this arm will be treated per their treating physician's choice.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Wake Forest Baptist Health Sciences Winston-Salem, NC

University of Michigan Ann Arbor, MI

University of North Carolina at Chapel Hill, Department of Radiation Oncology Chapel Hill, NC

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Patients Recruited

95,900+

University of North Carolina, Chapel Hill

Collaborator

Trials

1588

Patients Recruited

4,364,000+

University of Michigan

Collaborator

Trials

1891

Patients Recruited

6,458,000+

Wake Forest University Health Sciences

Collaborator

Trials

1432

Patients Recruited

2,506,000+