Brain Tumors, Central Nervous System Tumors
Conditions
Keywords
Brain neoplasm, Brain cancer, Neoplasm intracranial
Brief summary
The purpose of the study was to determine if treating a limited volume of normal tissue surrounding the tumor or tumor bed using conformal radiation therapy would achieve similar rates of disease control compared to standard radiation therapy. The study was also conducted to examine the effect of irradiation on neurological, endocrine and cognitive function.
Detailed description
Radiation therapy is commonly used to treat a variety of brain tumors in children including ependymoma, craniopharyngioma and low- and high-grade glioma. The ability of the therapy to control brain tumors in children is known to depend on the tumor type, extent of resection and other clinical factors. Children who received radiation therapy on this study were evaluated for treatment failure at 12 months. In addition to the primary objective, the study was designed to explore the association between radiation dose and volume and a variety of neurological, endocrine and cognitive deficits up to 5 years after treatment.
Interventions
PROCEDURERadiation Therapy
External Beam Radiation Therapy: 54Gy administered at 1.8Gy per day for low-grade glioma, craniopharyngioma and selected ependymoma.
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Months to 25 Years
Healthy volunteers
No
Inclusion criteria
* Age at time of irradiation is greater than or equal to 8 months and less than or equal to 25 years * Histologically diagnosed craniopharyngioma, ependymoma, low-grade astrocytoma or high-grade glioma and radiographically diagnosed selected patients with craniopharyngioma and low-grade glioma. * Adequate performance status, participant has an ECOG (Performance Status Score) of 0-2(0=Normal Activity; 1=Symptoms but Ambulatory; 2=Bedridden \<50% of time) * Histologic type that requires only focal irradiation. * No prior fractionated external beam irradiation * Informed consent signed by patient, parent, or guardian.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Control | 12 months after the enrollment of the last therapeutic patient | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 1cm Clinical Target Volume Margin - Ependymoma Patients with Ependymoma in the 1cm clinical target volume margin group. | 88 |
| 1cm Clinical Target Volume Margin - Low-grade Glioma Patients with Low-grade Glioma in the 1cm clinical target volume margin group. | 49 |
| 1cm Clinical Target Volume Margin - Craniopharyngioma Patients with Craniopharyngioma in the 1cm clinical target volume margin group. | 28 |
| 1cm Clinical Target Volume Margin - Other Remaining patients in the 1cm clinical target volume margin group. | 2 |
| 2cm Clinical Target Volume Margin - High-grade Glioma Patients with High-grade glioma in the 2cm clinical target volume margin group. | 34 |
| 2cm Clinical Target Volume Margin - Low-grade Glioma Patients with Low-grade Glioma in the 2cm clinical target volume margin group. | 1 |
| Total | 202 |
Baseline characteristics
| Characteristic | 1cm Clinical Target Volume Margin - Ependymoma | 1cm Clinical Target Volume Margin - Low-grade Glioma | 1cm Clinical Target Volume Margin - Craniopharyngioma | 1cm Clinical Target Volume Margin - Other | 2cm Clinical Target Volume Margin - High-grade Glioma | 2cm Clinical Target Volume Margin - Low-grade Glioma | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 86 Participants | 48 Participants | 28 Participants | 2 Participants | 26 Participants | 1 Participants | 191 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 8 Participants | 0 Participants | 11 Participants |
| Sex: Female, Male Female | 41 Participants | 24 Participants | 16 Participants | 1 Participants | 16 Participants | 0 Participants | 98 Participants |
| Sex: Female, Male Male | 47 Participants | 25 Participants | 12 Participants | 1 Participants | 18 Participants | 1 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 88 | 4 / 49 | 0 / 28 | 0 / 2 | 0 / 34 | 0 / 1 |
| serious Total, serious adverse events | 1 / 88 | 0 / 49 | 2 / 28 | 0 / 2 | 1 / 34 | 0 / 1 |
Outcome results
Primary
Local Tumor Control
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.
Time frame: 12 months after the enrollment of the last therapeutic patient
Population: Patients with Ependymoma, Craniopharyngioma, Low-grade Glioma, and High-grade Glioma were analyzed by diagnosis.
| Arm | Measure | Value (LOG_MEAN) |
|---|---|---|
| 1cm Clinical Target Volume Margin - Ependymoma | Local Tumor Control | 0.966 Proportion of patients |
| 1cm Clinical Target Volume Margin - Low-grade Glioma | Local Tumor Control | 0.959 Proportion of patients |
| 1cm Clinical Target Volume Margin - Craniopharyngioma | Local Tumor Control | 1.000 Proportion of patients |
| 1cm Clinical Target Volume Margin - Other | Local Tumor Control | 1.000 Proportion of patients |
| 2cm Clinical Target Volume Margin - High-grade Glioma | Local Tumor Control | 0.618 Proportion of patients |
| 2cm Clinical Target Volume Margin - Low-grade Glioma | Local Tumor Control | 1.000 Proportion of patients |