Clinical trial NCT02698254: Radiation Therapy in Treating Patients With Recurrent Brain Tumors Who Have Undergone Previous Radiation Therapy
Official title: Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Recurrent Brain Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-03
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot clinical trial studies the side effects and best dose of radiation therapy in patients with brain tumors that have come back after previous treatment with radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in different ways may kill more tumor cells.

Detailed description: PRIMARY OBJECTIVES:

I. To estimate the rate of grade 3 or higher central nervous system (CNS) necrosis 6 months after reirradiation of the brain for recurrent tumor.

SECONDARY OBJECTIVES:

I. To evaluate acute and late toxicities of reirradiation. II. To evaluate longitudinal changes in symptom burden of patients undergoing reirradiation.

III. To use Advanced Brain Tumor Imaging (ABTI) to evaluate changes in the brain after reirradiation, including progression, pseudoprogression, and radionecrosis.

IV. To estimate progression-free survival (PFS) and overall survival (OS) following reirradiation.

OUTLINE: Patients are assigned to 1 of 2 arms based on age.

ARM I (Age 0-18 years): Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II (Age \> 18 years): Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month, then every 2 months for 1 year, then every 3 months for 1 year.

Eligibility criteria: Inclusion Criteria:

* Previous pathologic confirmation of a tumor treated with radiation to the brain completed at least 6 months prior to the start of planned reirradiation, except for patients with tumors that are routinely diagnosed without biopsy, including germinoma and optic pathway glioma; patients with a history of cranial irradiation for leukemia are eligible
* Patient must have received one and only one previous course of radiation to the brain, delivered at 1.5 - 2.5 Gy/fraction, one fraction per day
* Multidisciplinary evaluation of the patient must be performed with a consensus recommendation for reirradiation
* Patient may not receive concurrent chemotherapy with reirradiation, other than temozolomide or bevacizumab given at the discretion of the treating neuro-oncologist
* Patient must have imaging findings within the last 3 months consistent with recurrent disease in the brain; pathologic diagnosis of recurrence is not required
* Patient may undergo surgical resection prior to reirradiation
* Dose-volume histogram data and cross-sectional imaging from previous radiation must be obtained; electronic dosimetry records in Digital Imaging and Communications in Medicine (DICOM) format from previous radiation are strongly preferred
* Signed informed consent by patient and/or parents or legal guardian
* Lansky/Karnofsky performance status score of 50-100

Exclusion Criteria:

* Patients with recurrent diffuse intrinsic pontine glioma (DIPG)
* Pregnancy

Primary outcomes:
measure: Highest grade of central nervous system (CNS) necrosis
timeFrame: At 6 months
Secondary outcomes:
measure: Incidence of acute and late toxicities
timeFrame: Up to 3.5 years
measure: Overall survival (OS) time
timeFrame: Up to 3.5 years
measure: Progression-free survival (PFS) time
timeFrame: Up to 3.5 years
measure: Quality of life
timeFrame: Up to 3.5 years
measure: Imaging changes as measured by Advanced Brain Tumor Imaging (ABTI)
timeFrame: Up to 3.5 years
Other outcomes:
measure: Symptom burden
timeFrame: Up to 3.5 years
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Susan L McGovern
role: PRINCIPAL_INVESTIGATOR
References: