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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


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

Thank you

Trial Information

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.


Inclusion Criteria:



1. All patients with histologic proof of malignant melanoma. Histologic confirmation may
be from the primary tumor site, or from another metastatic site (systemic lymph node,
etc). Cytology-alone is not an acceptable method of diagnosis.

2. Greater than 3 and less than or equal to 10 presumed melanoma brain metastases on
contrast-enhanced brain MRI scan obtained no greater than 4 weeks prior to study
registration

3. Patients must be age >/= 18 years.

4. Patients must sign informed consent indicating that they are aware of the
investigational nature of this study in keeping with the policies of the hospital.

5. Patients must have KPS >/=70

6. Patients must be eligible to have all lesions treated with SRS, including a maximum
diameter <3.5 cm for the largest lesion, as determined by the study radiation
oncologist.

7. Patients must have adequate renal/hematologic function, as defined by creatinine
clearance > 30ml/min and platelets>50,000.

8. Patients should have normal coagulation [International Normalized Ratio (INR) < 1.3]
and be able to withhold anticoagulation/antiplatelet medications a minimum of 24
hours prior to radiosurgery treatment (or until INR normalizes), on the day of
treatment and 24 hours after radiosurgery treatment has concluded. Patients
randomized to the WBRT arm may continue these therapies during treatment.

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

Exclusion Criteria:

1. Patients are excluded if they have had prior surgical resection of a melanoma brain
metastasis.

2. Patients are excluded if they have a history of metastatic cancer in addition to
melanoma or a history of non-metastatic cancer in the prior 2 years. Patients with
localized squamous cell carcinoma and/or basal cell carcinoma are not excluded.

3. Patients are excluded if they have had prior radiation (prophylactic cranial
irradiation, WBRT, SRS, or other) to the brain.

4. Patients are excluded if there is radiographic or cerebrospinal fluid (CSF) evidence
of leptomeningeal disease.

5. Female patients of childbearing age are excluded if they are pregnant as determined
with a serum beta HCG no greater than 14 days prior to study registration, or
breast-feeding. (The exclusion is made because gadolinium may be teratogenic in
pregnancy).

6. Patients are excluded if there is any history of gadolinium allergy.

7. Patients are excluded if they are unable to obtain a Magnetic resonance imaging (MRI)
scan for any other reason.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to Local Failure

Outcome Description:

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.

Outcome Time Frame:

4 months

Safety Issue:

Yes

Principal Investigator

Erik P. Sulman, MD,PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2011-0875

NCT ID:

NCT01644591

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Melanoma
  • Melanoma
  • Malignant melanoma
  • Brain Metastases
  • Stereotactic Radiosurgery
  • SRS
  • Whole Brain Radiation Therapy
  • WBRT
  • XRT
  • Melanoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030