Trial Outcomes & Findings for A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects (NCT NCT00187226)
NCT ID: NCT00187226
Last Updated: 2023-05-31
Results Overview
Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
361 participants
Primary outcome timeframe
12 months after the enrollment of the last therapeutic patient
Results posted on
2023-05-31
Participant Flow
202 patients were enrolled between July 11, 1997 and January 14, 2003 for the therapeutic phase of the trial. Among those patients, 167 were treated with a 1cm clinical target volume (CTV) margin and 35 were treated with a 2cm CTV margin. Local tumor progression was determined by MR imaging. 202 patients correspond to the initial number of patients enrolled prior to the amendment which increased accrual 361
Participant milestones
| Measure |
1cm Clinical Target Volume Margin - Ependymoma
Patients with Ependymoma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Low-grade Glioma
Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Craniopharyngioma
Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Other
Remaining patients in the 1cm clinical target volume margin group.
|
2cm Clinical Target Volume Margin - High-grade Glioma
Patients with High-grade glioma in the 2cm clinical target volume margin group.
|
2cm Clinical Target Volume Margin - Low-grade Glioma
Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
88
|
49
|
28
|
2
|
34
|
1
|
|
Overall Study
COMPLETED
|
88
|
49
|
28
|
2
|
34
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study for Image-Guided Radiation Therapy in Pediatric Brain Tumors and Side Effects
Baseline characteristics by cohort
| Measure |
1cm Clinical Target Volume Margin - Ependymoma
n=88 Participants
Patients with Ependymoma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Low-grade Glioma
n=49 Participants
Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Craniopharyngioma
n=28 Participants
Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Other
n=2 Participants
Remaining patients in the 1cm clinical target volume margin group.
|
2cm Clinical Target Volume Margin - High-grade Glioma
n=34 Participants
Patients with High-grade glioma in the 2cm clinical target volume margin group.
|
2cm Clinical Target Volume Margin - Low-grade Glioma
n=1 Participants
Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
86 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
191 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
98 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
104 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 months after the enrollment of the last therapeutic patientPopulation: Patients with Ependymoma, Craniopharyngioma, Low-grade Glioma, and High-grade Glioma were analyzed by diagnosis.
Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation.
Outcome measures
| Measure |
1cm Clinical Target Volume Margin - Ependymoma
n=88 Participants
Patients with Ependymoma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Low-grade Glioma
n=49 Participants
Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Craniopharyngioma
n=28 Participants
Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Other
n=2 Participants
Remaining patients in the 1cm clinical target volume margin group.
|
2cm Clinical Target Volume Margin - High-grade Glioma
n=34 Participants
Patients with High-grade glioma in the 2cm clinical target volume margin group.
|
2cm Clinical Target Volume Margin - Low-grade Glioma
n=1 Participants
Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
|
|---|---|---|---|---|---|---|
|
Local Tumor Control
|
0.966 Proportion of patients
Interval 0.904 to 0.993
|
0.959 Proportion of patients
Interval 0.86 to 0.995
|
1.000 Proportion of patients
Interval 0.877 to 1.0
|
1.000 Proportion of patients
Interval 1.0 to 1.0
|
0.618 Proportion of patients
Interval 0.436 to 0.778
|
1.000 Proportion of patients
Interval 1.0 to 1.0
|
Adverse Events
1cm Clinical Target Volume Margin - Ependymoma
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
1cm Clinical Target Volume Margin - Low-grade Glioma
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1cm Clinical Target Volume Margin - Craniopharyngioma
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
1cm Clinical Target Volume Margin - Other
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2cm Clinical Target Volume Margin - High-grade Glioma
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
2cm Clinical Target Volume Margin - Low-grade Glioma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1cm Clinical Target Volume Margin - Ependymoma
n=88 participants at risk
Patients with Ependymoma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Low-grade Glioma
n=49 participants at risk
Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Craniopharyngioma
n=28 participants at risk
Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Other
n=2 participants at risk
Remaining patients in the 1cm clinical target volume margin group.
|
2cm Clinical Target Volume Margin - High-grade Glioma
n=34 participants at risk
Patients with High-grade glioma in the 2cm clinical target volume margin group.
|
2cm Clinical Target Volume Margin - Low-grade Glioma
n=1 participants at risk
Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
CNS Ischemia
|
0.00%
0/88 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/49 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
3.6%
1/28 • Number of events 1 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/2 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/34 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/1 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
|
General disorders
Death
|
0.00%
0/88 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/49 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
3.6%
1/28 • Number of events 1 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/2 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/34 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/1 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/88 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/49 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/28 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/2 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
2.9%
1/34 • Number of events 1 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/1 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.1%
1/88 • Number of events 1 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/49 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/28 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/2 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/34 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/1 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
Other adverse events
| Measure |
1cm Clinical Target Volume Margin - Ependymoma
n=88 participants at risk
Patients with Ependymoma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Low-grade Glioma
n=49 participants at risk
Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Craniopharyngioma
n=28 participants at risk
Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
|
1cm Clinical Target Volume Margin - Other
n=2 participants at risk
Remaining patients in the 1cm clinical target volume margin group.
|
2cm Clinical Target Volume Margin - High-grade Glioma
n=34 participants at risk
Patients with High-grade glioma in the 2cm clinical target volume margin group.
|
2cm Clinical Target Volume Margin - Low-grade Glioma
n=1 participants at risk
Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Infection
|
10.2%
9/88 • Number of events 12 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/49 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/28 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/2 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/34 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/1 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
|
Nervous system disorders
Neuromotor
|
0.00%
0/88 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
8.2%
4/49 • Number of events 4 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/28 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/2 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/34 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
0.00%
0/1 • Patients enrolled on this study included 202 patients who were enrolled between July 11, 1997 and January 14, 2003. Patients are followed 30 days post off-study.
|
Additional Information
Thomas E. Merchant, DO, PhD
St. Jude Children's Research Hospital
Phone: 901-595-3604
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place