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A Prospective Phase III Trial to Compare Stereotactic Radiosurgery Versus Whole Brain Radiation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01592968
First received: May 3, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

The goal of this clinical research study is to compare stereotactic radiosurgery to whole brain radiation therapy in patients with 4-10 non-melanoma brain tumors.

Stereotactic radiosurgery is the delivery of focused, high-dose radiation given in a single session to the tumors with a minimal dose given to uninvolved areas of the brain.

Whole brain radiation is the delivery of lower dose radiation to the entire brain given daily over 2 weeks.


Condition Intervention Phase
Brain Neoplasms
Radiation: Stereotactic Radiosurgery (SRS)
Radiation: Whole Brain Radiation Therapy (WBRT)
Behavioral: Questionnaires
Behavioral: Cognitive Function Tests
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Phase III Randomized Trial to Compare Stereotactic Radiosurgery Versus Whole Brain Radiation Therapy for >/= 4 Newly Diagnosed Non-Melanoma Brain Metastases

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Local Tumor Control [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Lesions assessed using contrast-enhanced MRI scans. Progressive disease (PD) considered local failure, or stable disease with deterioration of neurological examination with a grade III or worse toxicity on the CTC AE v.4.0 scale. Local control measured by contrast-enhanced brain MRI scan using modified RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in sum of diameters of target lesions. Progressive Disease (PD): At least a 20% increase in sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For local control, PD considered local failure, or stable disease with deterioration of neurological examination with a grade III or worse toxicity on the CTC AE v.4.0 scale. All others (CR, PR, asymptomatic SD) are deemed success.

  • Cognitive Decline [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Baseline Hopkins Verbal Learning Testing-Revised (HVLT-R) score compared to HVLT-R score in patients surviving 4 months. Preservation of function defined as improvement of HVLT-R score or decline by 4 points or less. Failure defined as decline by 5 or more points. Time to neurocognitive decline estimated for each treatment arm using product limit estimator of Kaplan and Meier.


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Radiosurgery (SRS)
Dose based on largest diameter lesion as measured on volumetric MRI, modified as follows: 20-24 Gy for lesions 2 cm or less in size, 16-18 Gy for lesions >2-2.5 cm in size, and 12-16 Gy for lesions >2.5-3.5 cm in size. SRS performed on day 1.
Radiation: Stereotactic Radiosurgery (SRS)
Dose based on largest diameter lesion as measured on volumetric MRI, as follows: 20-24 Gy for lesions 2 cm or less in size, 16-18 Gy for lesions >2-2.5 cm in size, and 12-16 Gy for lesions >2.5-3.5 cm in size. SRS performed on day 1.
Other Names:
  • XRT
  • Radiation therapy
Behavioral: Questionnaires
Three (3) sets of quality of life (QOL) questionnaires completed 1, 4, 6, 9, and 12 months after assigned treatment.
Other Name: Surveys
Behavioral: Cognitive Function Tests
7 cognitive function tests completed 1, 4, 6, 9, and 12 months after assigned treatment.
Experimental: Whole Brain Radiation Therapy (WBRT)
Fractionated radiation delivered to whole brain daily to deliver a dose of 30 Gy in 10 fractions.
Radiation: Whole Brain Radiation Therapy (WBRT)
Fractionated radiation delivered to whole brain daily to deliver a dose of 30 Gy in 10 fractions.
Other Names:
  • XRT
  • Radiation therapy
Behavioral: Questionnaires
Three (3) sets of quality of life (QOL) questionnaires completed 1, 4, 6, 9, and 12 months after assigned treatment.
Other Name: Surveys
Behavioral: Cognitive Function Tests
7 cognitive function tests completed 1, 4, 6, 9, and 12 months after assigned treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 is radiographic or CSF cytological evidence of leptomeningeal disease.
  4. Patients will be excluded if they have had prior radiation to the brain (either WBRT, prophylactic cranial irradiation (PCI), or SRS).
  5. 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.
  6. Patients will be excluded if they are unable to obtain an MRI scan.
  7. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592968

Contacts
Contact: Jing Li, MD 713-563-2300

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jing Li, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01592968     History of Changes
Other Study ID Numbers: 2011-0884, NCI-2012-00850
Study First Received: May 3, 2012
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Brain Neoplasms
Non-melanoma brain metastases
Stereotactic radiosurgery
SRS
Whole brain radiation therapy
WBRT

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014