Trial Outcomes & Findings for Radiation Therapy in Treating Young Patients With Gliomas (NCT NCT00238264)

Last Updated: 2019-08-07

Results Overview

Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

92 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2019-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Reduced-field Conformal Radiation Therapy Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Overall Study STARTED	92
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Reduced-field Conformal Radiation Therapy Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Overall Study Death	7
Overall Study Lost to Follow-up	18
Overall Study Withdrawal by Subject	4
Overall Study Ineligible	7

Baseline Characteristics

Radiation Therapy in Treating Young Patients With Gliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reduced-field Conformal Radiation Therapy n=92 Participants Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Age, Categorical <=18 years	86 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	13.6 Years n=99 Participants
Sex: Female, Male Female	49 Participants n=99 Participants
Sex: Female, Male Male	43 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	9 Participants n=99 Participants
Race (NIH/OMB) White	75 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: All evaluable patients were included in this analysis (n = 84). One eligible patient was deemed to be not evaluable due to progression during treatment, and was excluded from the analysis per protocol.

Outcome measures

Outcome measures
Measure	Reduced-field Conformal Radiation Therapy n=84 Participants Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Marginal-failure Rate	0 percentage of failure rate

SECONDARY outcome

Timeframe: 3 years

Population: All eligible patients were included in the analysis, per protocol.

To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.

Outcome measures

Outcome measures
Measure	Reduced-field Conformal Radiation Therapy n=85 Participants Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Progression-free Survival Probability	77.1 Percentage 3-year PFS rate Interval 68.5 to 86.7

SECONDARY outcome

Timeframe: 3 years

Population: All eligible patients were included in the analysis, per protocol.

To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation

Outcome measures

Outcome measures
Measure	Reduced-field Conformal Radiation Therapy n=85 Participants Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Event-free Survival Probability	77.1 Percentage 3-year EFS rate Interval 68.5 to 86.7

SECONDARY outcome

Timeframe: 3 years

Population: All eligible patients were included in the analysis, per protocol.

To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.

Outcome measures

Outcome measures
Measure	Reduced-field Conformal Radiation Therapy n=85 Participants Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Overall Survival Probability	94.0 Percentage 3-year OS rate Interval 89.1 to 99.2

SECONDARY outcome

Timeframe: Up to 5 years

Population: The QOL assessments were removed from the protocol as part of Amendment #1A (as of 10/27/2010) due to extremely low compliance. No QOL data were available for statistical analysis.

QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline

Population: All eligible patients with MIB-1 labeling index available.

The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.

Outcome measures

Outcome measures
Measure	Reduced-field Conformal Radiation Therapy n=64 Participants Reduced-field conformal radiation therapy 5 days a week for 6 weeks
MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods	3.1 percentage of tumor nuclei Interval 2.4 to 3.8

SECONDARY outcome

Timeframe: Up to 10 years

Population: All eligible patients with MIB-1 data available were included in this analysis. Per protocol, patients were stratified by age and tumor location. Based on a predefined cutoff, patients were categorized as MIB high or low (high: \>= 2; low: \< 2). The hazard ratio below is for patients with MIB high (low is the reference level).

The primary methods of analysis will be via stratified Cox regression

Outcome measures

Outcome measures
Measure	Reduced-field Conformal Radiation Therapy n=64 Participants Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Correlation MIB-1 Labeling Index With PFS	1.08 Hazard ratio Interval 0.42 to 2.81

Adverse Events

Reduced-field Conformal Radiation Therapy

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Reduced-field Conformal Radiation Therapy n=85 participants at risk Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Eye disorders Periorbital edema	1.2% 1/85 • Number of events 1
Blood and lymphatic system disorders Anemia	1.2% 1/85 • Number of events 1
Metabolism and nutrition disorders Hypernatremia	1.2% 1/85 • Number of events 1
Metabolism and nutrition disorders Hypokalemia	1.2% 1/85 • Number of events 1
Metabolism and nutrition disorders Hyponatremia	1.2% 1/85 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	1.2% 1/85 • Number of events 1
Nervous system disorders Abducens nerve disorder	1.2% 1/85 • Number of events 1
Nervous system disorders Encephalopathy	1.2% 1/85 • Number of events 1
Nervous system disorders Hydrocephalus	2.4% 2/85 • Number of events 2
Nervous system disorders Nervous system disorders - Other, specify	1.2% 1/85 • Number of events 1
Nervous system disorders Neuralgia	1.2% 1/85 • Number of events 1
Nervous system disorders Oculomotor nerve disorder	1.2% 1/85 • Number of events 1
Nervous system disorders Peripheral sensory neuropathy	1.2% 1/85 • Number of events 1
Nervous system disorders Tremor	1.2% 1/85 • Number of events 1
Nervous system disorders Trigeminal nerve disorder	1.2% 1/85 • Number of events 1
Psychiatric disorders Depression	1.2% 1/85 • Number of events 1

Other adverse events

Other adverse events
Measure	Reduced-field Conformal Radiation Therapy n=85 participants at risk Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Nervous system disorders Headache	5.9% 5/85 • Number of events 5

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
Publication restrictions are in place

Restriction type: OTHER