A Prospective Phase III Randomized Trial to Compare Stereotactic Radiosurgery Versus Whole Brain Radiation Therapy for >/= 4 Newly Diagnosed Non-Melanoma Brain Metastases
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being
assigned to either group:
- If you are in Group 1, you will receive whole brain radiation treatment.
- If you are in Group 2, you will receive stereotactic radiosurgery.
Study Procedures:
If you are in Group 1, you will receive whole brain radiation treatment each day,
Monday-Friday starting on Day 1. If you are an inpatient, you may receive radiation
treatment on weekends as well. You will continue to receive radiation treatment up to Day
14.
If you are in Group 2, you will receive stereotactic radiosurgery on Day 1. As part of the
stereotactic radiosurgery procedure, you will receive a very accurate kind of MRI scan on
the morning of the procedure. If this MRI scan identifies more tumors, you may still
continue to participate in the study with up to 15 tumors. If there are more than 15 tumors
found on the treatment planning MRI scan on the day of the SRS treatment, then you are not
eligible to participate in the study. In this case, your study doctor will discuss with you
other treatment options off of the study, which may include stereotactic radiosurgery and/or
whole brain radiation therapy.
No matter which group you are in, you will sign a separate consent form for whole brain
radiation or stereotactic radiosurgery that will explain the procedures and risks in detail.
Study Visits:
At 1, 4, 6, 9, and 12 months (+/- 14 days) after your assigned treatment, you will return to
the clinic:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any drugs you may be taking.
- You will have an MRI scan to check the status of the disease.
- You will complete the 7 cognitive function tests.
- You will complete 3 questionnaires that ask about your quality of life and any symptoms
you may be having.
Length of Study Participation:
Your active participation on the study will be over when you have completed the follow-up
visits.
Follow-Up Visits:
If the study doctor thinks it is needed, you will return to the clinic for follow-up visits.
The following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about any drugs you may be taking.
- You will have an MRI to check the status of the disease.
This is an investigational study. It is considered investigational to compare stereotactic
radiosurgery to whole brain radiation therapy in patients with 4-10 non-melanoma brain
tumors.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Local Tumor Control
Local control rates estimated at 4 months for each treatment arm with 95% confidence intervals based on the Kaplan-Meier estimates of time to local failure. Logrank test stratified by stratification factors used at randomization to compare the 2 treatment arms with respect to time to local failure. Lesions assessed using contrast-enhanced MRI scans. Progressive disease (PD) is considered local failure, or stable disease with deterioration of the neurological examination with a grade III or worse toxicity on the CTC AE v.4.0 scale.
4 months
No
Stephen Settle, MD,PHD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2011-0884
NCT01592968
August 2012
Name | Location |
---|---|
UT MD Andreson Cancer Center | Houston, Texas 77030 |