Know Cancer

or
forgot password

A Prospective Phase III Randomized Trial to Compare Stereotactic Radiosurgery Versus Whole Brain Radiation Therapy for >/= 4 Newly Diagnosed Non-Melanoma Brain Metastases


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Brain Neoplasms

Thank you

Trial Information

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.


Inclusion Criteria:



1. All patients must have histological proof of malignant cancer, which is metastatic.
Histological proof may be obtained from the primary tumor or another metastatic site.
However, cytology alone is not an acceptable method of diagnosis.

2. All patients must have greater than 3 but less than or equal to 10 metastatic lesions
seen on a contrast enhancing MRI scan obtained not less than one month prior to study
enrollment. Patients who are found to have 11-15 metastatic lesions at the time of
treatment planning (on volumetric MRI once the head frame is in place) may still
participate in the trial.

3. All patients must be >/= 18 years of age.

4. All patients must sign informed consent verifying that they are aware of the
investigational nature of this study in keeping with the rules and policies of M.D.
Anderson Cancer Center. The only acceptable consent form is the one attached at the
end of this protocol, and it must have been approved and amended by the M.D. Anderson
IRB.

5. All patients must be eligible to have all lesions treated with SRS (i.e. maximum
diameter of largest lesion < 3.5cm) as determined by the study radiation oncologist .

6. All patients must have adequate liver, renal, and hematologic function as defined by
Aspartate Amino Transferase (AST)/Alanine Amino Transferase (ALT)/Alkaline
Phosphatase < 2.5 times normal, calculated creatinine clearance > 30ml/min, and
platelet count > 50,000.

7. All patients should have normal coagulation, with international normalized ratio
(INR) < 1.3 and able to withhold anti-coagulation medications a minimum of 24 hours
prior to radiosurgery (or until INR normalizes), on the day of treatment and 24 hours
after radiosurgery has concluded. Those patients getting WBRT may continue these
medications.

8. Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the
discretion of their treating oncologist.

Exclusion Criteria:

1. Patients are excluded from this trial if they have melanoma, small cell carcinoma,
lymphoma/leukemia, or germ cell histology (note, melanoma patients will be eligible
for the sister trial to this trial which will be open simultaneously).

2. Patients will be excluded if they have had prior surgical resection of metastatic
cancer from the brain.

3. Patients will be excluded if there are one or more lesions in the brainstem.

4. Patients will be excluded if there is radiographic or CSF cytological evidence of
leptomeningeal disease.

5. Patients will be excluded if they have had prior radiation to the brain (either WBRT,
prophylactic cranial irradiation (PCI), or SRS).

6. Female patients of childbearing age will be excluded if they are pregnant as assessed
by serum b-HCG or urine pregnancy test. A serum b-HCG test or urine pregnancy test
will be performed no greater than 14 days prior to study registration.

7. Patients will be excluded if they are unable to obtain an MRI scan.

8. Patients will be excluded if they have < 4 lesions, or > 10 lesions at enrollment or
> 15 lesions at the time of treatment (note: patients who qualify for enrollment
based on having 4-10 lesions, but who are discovered to have 11-15 lesions on the
volumetric MRI used for treatment planning will be allowed to continue on study).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local Tumor Control

Outcome Description:

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.

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Stephen Settle, MD,PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2011-0884

NCT ID:

NCT01592968

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Brain Neoplasms
  • Brain Neoplasms
  • Non-melanoma brain metastases
  • Stereotactic radiosurgery
  • SRS
  • Whole brain radiation therapy
  • WBRT
  • Brain Neoplasms
  • Neoplasms

Name

Location

UT MD Andreson Cancer CenterHouston, Texas  77030