A Prospective Randomized Phase III Trial to Compare Local Control and Neurocognitive Preservation After Initial Treatment With Stereotactic Radiosurgery (SRS) Versus Whole Brain Radiation Therapy (WBRT) for Patients With >3 Brain Metastases From Melanoma
Study Groups:
If you are found to be eligible and you agree 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 WBRT.
- If you are in Group 2, you will receive SRS.
Study Procedures:
If you are in Group 1, you will receive WBRT 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. As such, there will be up to 14 days
of treatment if you are in Group 1.
If you are in Group 2, you will receive SRS on Day 1. There will be 1 day of treatment if
you are in Group 2.
No matter which group you are in, you will sign a separate consent form for WBRT or SRS that
will explain the procedures and risks in detail.
Study Visits:
At 1, 6, and 9 months (+/- 14 days) after Day 1, the following tests and procedures will be
performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have an MRI to check the status of the disease.
- You will complete the same 7 cognitive function tests and 3 questionnaires you
completed at screening.
At 4 and 12 months (+/- 14 days) after Day 1, the following tests and procedures will be
performed:
- You will have a physical exam, including measurement of your vital signs.
- You will have an MRI to check the status of the disease.
- You will have a whole body PET scan to check the status of the disease and to check the
effects of the disease on your thinking and brain functions.
- You will complete the same 7 cognitive function tests and 3 questionnaires you
completed at screening.
If the disease returns after treatment, you may receive either WBRT or additional SRS. Your
treatment options will be discussed with you.
Length of Study Participation:
Your active participation on the study will be over when you have completed the Month 12
visit.
If you are in Group 2 and an MRI scan shows that you have more than 15 lesions, you will be
withdrawn from the study. Your doctor(s) will discuss future treatment options with you.
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.
Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Local Failure
Time to local failure estimated using product-limit estimator of Kaplan and Meier for each treatment arm. Local control and distal control in brain measured by contrast-enhanced brain MRI scan using modified RECIST criteria. For local control, progressive disease (PD) is considered local failure, or stable disease with deterioration of neurological examination with a grade III or worse toxicity on the CTCAE v4.0 nervous system disorders toxicity grading scale. All others complete response (CR), partial response (PR), asymptomatic stable disease (SD) are deemed success.
4 months
Yes
Erik P. Sulman, MD,PHD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0875
NCT01644591
August 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |