Trial Outcomes & Findings for Trial of Parotid Sparing Whole Brain Radiation (NCT NCT03595878)

Last Updated: 2025-04-25

Results Overview

Between baseline and 1 month after the treatment xerostomia symptoms were assessed, in 2 randomized groups namely Arm A and Arm B. Xerostomia symptoms were assessed using the patient-reported study xerostomia questionnaire. The questionnaire includes 8 questions, and each question score changes between 0 to 10. The increasing value represents worse xerostomia symptoms. No xerostomia symptom= 0 and highest xerostomia symptom=10. The total score will be on a scale from 0-80 (8 categories with a maximum score of 10). Changes in xerostomia symptoms in each arm were tabulated. Positive values represent increased xerostomia symptoms and negative values represent decreasing xerostomia symptoms and no difference is no change.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Up to 45 days

Results posted on

2025-04-25

Participant Flow

Participants were recruited from 05/09/2018 through 02/03/2021 at 3 cancer centers in the United States.

Sixty subjects were included in the study: 56 subjects were randomized into 2 groups: Group A (29 subjects) and Group B (27 subjects), and 4 subjects who started therapy according to physician choice, were included in Group C.

Participant milestones

Participant milestones
Measure	Arm A: Randomized Control Group Subjects received standard whole-brain radiation therapy	Arm B: Randomized Intervention Group Subjects received standard whole-brain radiation therapy with avoidance of the parotid glands.	Arm C: Observational Arm Subjects enrolled in this arm per their physician's choice, received standard whole-brain radiation therapy.
Overall Study STARTED	29	27	4
Overall Study COMPLETED	25	25	2
Overall Study NOT COMPLETED	4	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Randomized Control Group Subjects received standard whole-brain radiation therapy	Arm B: Randomized Intervention Group Subjects received standard whole-brain radiation therapy with avoidance of the parotid glands.	Arm C: Observational Arm Subjects enrolled in this arm per their physician's choice, received standard whole-brain radiation therapy.
Overall Study Death	2	1	0
Overall Study Disease progression	2	1	2

Baseline Characteristics

Trial of Parotid Sparing Whole Brain Radiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A:RandomizedControl Group n=29 Participants Subjects received standard whole-brain radiation therapy	Arm B:RandomizedIntervention Group n=27 Participants Subjects received standard whole-brain radiation therapy with avoidance of the parotid glands.	Arm C:Observational Arm n=4 Participants Subjects enrolled in this arm per their physician's choice, received standard whole-brain radiation therapy.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	15 Participants n=7 Participants	4 Participants n=5 Participants	39 Participants n=4 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	12 Participants n=7 Participants	0 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	1 Participants n=5 Participants	35 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	25 Participants n=7 Participants	4 Participants n=5 Participants	58 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	22 Participants n=7 Participants	3 Participants n=5 Participants	52 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	29 participants n=5 Participants	27 participants n=7 Participants	4 participants n=5 Participants	60 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 45 days

Population: Subjects were randomized in 2 randomized groups namely Arm A and Arm B, completed the treatment, and responded to the quality-of-life questionnaire, both at baseline and after 1 month after completion of treatment. Arm C was not included since Arm C is not a randomized arm.

Outcome measures

Outcome measures
Measure	Randomized Arm - Control Group n=15 Participants Subjects randomized to this group receive Standard Whole Brain Radiation Therapy (WBRT).	Randomized Arm - Intervention Group n=18 Participants Subjects randomized to this group will receive parotid-sparing Whole Brain Radiation Therapy (WBRT), with avoidance of the parotid glands.	Arm C : Not- Randomized Arm Observational Arm Patients enrolled in this arm were not randomized, they are enrolled per their treating physician's choice.
Xerostomia One Month After Completion of Treatment Improved: Decreased xerostomia symptoms	5 Participants	7 Participants	—
Xerostomia One Month After Completion of Treatment No Change in xerostomia symptoms	1 Participants	6 Participants	—
Xerostomia One Month After Completion of Treatment Worsened: Increased xerostomia symptoms	9 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Up to 6 months

Population: The subjects completed the treatment and were assessed for the occurrence of marginal relapse.

The number of subjects with marginal cervical spine relapse in each randomization arm.

Outcome measures

Outcome measures
Measure	Randomized Arm - Control Group n=15 Participants Subjects randomized to this group receive Standard Whole Brain Radiation Therapy (WBRT).	Randomized Arm - Intervention Group n=14 Participants Subjects randomized to this group will receive parotid-sparing Whole Brain Radiation Therapy (WBRT), with avoidance of the parotid glands.	Arm C : Not- Randomized Arm Observational Arm n=1 Participants Patients enrolled in this arm were not randomized, they are enrolled per their treating physician's choice.
Freedom From Relapse Number of subject with marginal relapse	0 Participants	0 Participants	0 Participants
Freedom From Relapse Number of subject without marginal relapse	15 Participants	14 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 45 days

Population: Subjects completed the treatment and responded to the quality-of-life questionnaire both at baseline and one month after the treatment.

Between baseline and 1 month after the treatment xerostomia symptoms were assessed and tabulated based on the whole brain radiotherapy (WBRT) technique. The Standard WBRT Group includes both randomized (Group A) and non-randomized (Group C) subjects who received WBRT. The Parotid Sparing WBRT Group includes subjects who were randomized and received Parotid Sparing WBRT (Group B). Xerostomia symptoms were assessed using the patient-reported study xerostomia questionnaire. The questionnaire includes 8 questions, and each question score changes between 0 to 10. The increasing value represents worse xerostomia symptoms. No xerostomia symptom= 0 and highest xerostomia symptom=10. The total score will be on a scale from 0-80 (8 categories with a maximum score of 10). Changes were tabulated as: Positive values represent worsened xerostomia symptoms, and both negative values and no change values represent did not worsen.

Outcome measures

Outcome measures
Measure	Randomized Arm - Control Group n=15 Participants Subjects randomized to this group receive Standard Whole Brain Radiation Therapy (WBRT).	Randomized Arm - Intervention Group n=18 Participants Subjects randomized to this group will receive parotid-sparing Whole Brain Radiation Therapy (WBRT), with avoidance of the parotid glands.	Arm C : Not- Randomized Arm Observational Arm n=1 Participants Patients enrolled in this arm were not randomized, they are enrolled per their treating physician's choice.
Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment Xerostomia Worsened	9 Participants	5 Participants	0 Participants
Xerostomia Based on Radiotherapy Treatment Fields- One Month After the Treatment Xerostomia did not worsen	6 Participants	13 Participants	1 Participants

Adverse Events

Arm A:Randomized Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B:Randomized Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm C: Observational Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Colette Shen

University of North Carolina Lineberger Comprehensive Cancer Center

Phone: +1 984-974-0400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators' joint publication is required.
Publication restrictions are in place

Restriction type: OTHER