Trial Outcomes & Findings for Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma (NCT NCT00681473)
NCT ID: NCT00681473
Last Updated: 2017-03-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
5 years
Results posted on
2017-03-07
Participant Flow
A large number of patients with brain tumors in the greater area are referred to one or more of the MGH multidisciplinary brain tumor specialists for evaluation and further care.
Participant milestones
| Measure |
Proton Radiation Therapy
Proton Radiation Therapy daily (Monday through Friday) for six weeks. This is a single arm study.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma
Baseline characteristics by cohort
| Measure |
Proton Radiation Therapy
n=20 Participants
Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
|
|---|---|
|
Age, Continuous
|
37.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Proton Radiation Therapy
n=20 Participants
Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
|
|---|---|
|
Number of Participants With Late Effects > 3 Months Post RT
|
20 Participants
|
SECONDARY outcome
Timeframe: At 1, 3, and 5 yearsClinical and/or radiographic assessments Percentages were estimated by Kaplan Meier
Outcome measures
| Measure |
Proton Radiation Therapy
n=20 Participants
Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
|
|---|---|
|
Percentage of Participants With Progression Free Survival
1 Year
|
100 % of participants
|
|
Percentage of Participants With Progression Free Survival
3 Year
|
85 % of participants
|
|
Percentage of Participants With Progression Free Survival
5 Year
|
40 % of participants
|
SECONDARY outcome
Timeframe: At 1, 3, and 5 yearsPercentages were estimated by Kaplan Meier
Outcome measures
| Measure |
Proton Radiation Therapy
n=20 Participants
Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
|
|---|---|
|
Percentage of Participants With Overall Survival
1 Year
|
100 % of participants
|
|
Percentage of Participants With Overall Survival
3 Year
|
95 % of participants
|
|
Percentage of Participants With Overall Survival
5 Year
|
84 % of participants
|
Adverse Events
Proton Radiation Therapy
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Proton Radiation Therapy
n=20 participants at risk
Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
|
|---|---|
|
General disorders
fatigue, acute
|
100.0%
20/20 • Number of events 20 • Up to 5 years post RT
|
|
Skin and subcutaneous tissue disorders
Erythema
|
85.0%
17/20 • Number of events 17 • Up to 5 years post RT
|
|
General disorders
Headache, acute
|
75.0%
15/20 • Number of events 15 • Up to 5 years post RT
|
|
Nervous system disorders
Seizure, acute
|
25.0%
5/20 • Number of events 5 • Up to 5 years post RT
|
|
General disorders
Taste/Smell Alteration, acute
|
15.0%
3/20 • Number of events 3 • Up to 5 years post RT
|
|
General disorders
Anorexia
|
10.0%
2/20 • Number of events 2 • Up to 5 years post RT
|
|
Skin and subcutaneous tissue disorders
Alopecia, acute
|
85.0%
17/20 • Number of events 17 • Up to 5 years post RT
|
|
Nervous system disorders
Cognitive Deficit
|
5.0%
1/20 • Number of events 1 • Up to 5 years post RT
|
|
Gastrointestinal disorders
Nausea/Vomiting, acute
|
20.0%
4/20 • Number of events 4 • Up to 5 years post RT
|
|
General disorders
Paresthesia, acute
|
10.0%
2/20 • Number of events 2 • Up to 5 years post RT
|
|
Nervous system disorders
Dizziness, acute
|
10.0%
2/20 • Number of events 2 • Up to 5 years post RT
|
|
Nervous system disorders
Anxiety
|
10.0%
2/20 • Number of events 2 • Up to 5 years post RT
|
|
General disorders
Insomnia, acute
|
10.0%
2/20 • Number of events 2 • Up to 5 years post RT
|
|
Nervous system disorders
Motor Dysfunction
|
10.0%
2/20 • Number of events 2 • Up to 5 years post RT
|
|
Eye disorders
Photophobia
|
5.0%
1/20 • Number of events 1 • Up to 5 years post RT
|
|
Skin and subcutaneous tissue disorders
Itching
|
5.0%
1/20 • Number of events 1 • Up to 5 years post RT
|
|
Ear and labyrinth disorders
Hearing
|
20.0%
4/20 • Number of events 4 • Up to 5 years post RT
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Number of events 1 • Up to 5 years post RT
|
|
General disorders
Temperature Sensitivity
|
15.0%
3/20 • Number of events 3 • Up to 5 years post RT
|
|
Nervous system disorders
Weakness, cranial nerve
|
15.0%
3/20 • Number of events 3 • Up to 5 years post RT
|
|
Nervous system disorders
Weakness, peripheral
|
10.0%
2/20 • Number of events 2 • Up to 5 years post RT
|
|
General disorders
Stuttering, twitching
|
5.0%
1/20 • Number of events 1 • Up to 5 years post RT
|
|
Nervous system disorders
Cognitive dysarthria
|
5.0%
1/20 • Number of events 1 • Up to 5 years post RT
|
|
Eye disorders
Visual disturbance, other than loss
|
15.0%
3/20 • Number of events 3 • Up to 5 years post RT
|
|
Eye disorders
Vision Loss
|
5.0%
1/20 • Number of events 1 • Up to 5 years post RT
|
|
Nervous system disorders
Proprioceptive deficit
|
5.0%
1/20 • Number of events 1 • Up to 5 years post RT
|
|
General disorders
fatigue, late
|
85.0%
17/20 • Number of events 17 • Up to 5 years post RT
|
|
Gastrointestinal disorders
headache, late
|
75.0%
15/20 • Number of events 15 • Up to 5 years post RT
|
|
Nervous system disorders
Seizure, late
|
20.0%
4/20 • Number of events 4 • Up to 5 years post RT
|
|
General disorders
Taste/smell alteration, late
|
5.0%
1/20 • Number of events 1 • Up to 5 years post RT
|
|
Skin and subcutaneous tissue disorders
Alopecia, late
|
60.0%
12/20 • Number of events 12 • Up to 5 years post RT
|
|
Gastrointestinal disorders
Nausea/Vomiting, late
|
15.0%
3/20 • Number of events 3 • Up to 5 years post RT
|
|
General disorders
Paresthesia, late
|
15.0%
3/20 • Number of events 3 • Up to 5 years post RT
|
|
Nervous system disorders
Dizziness, late
|
30.0%
6/20 • Number of events 6 • Up to 5 years post RT
|
|
Gastrointestinal disorders
Insomnia, late
|
15.0%
3/20 • Number of events 3 • Up to 5 years post RT
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place