Randomized Trial Comparing Radiosurgery With vs Without Whole Brain Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00548756
Recruitment Status : Active, not recruiting
First Posted : October 24, 2007
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if your thinking ability (cognitive function) will be better preserved by delivering whole brain radiation therapy immediately after radiosurgical treatment of 1-3 brain metastases or to carefully observe patients after radiosurgery and hold back whole brain radiation therapy until the disease comes back.

Condition or disease Intervention/treatment Phase
Brain Cancer Procedure: Whole Brain Radiation Therapy Other: Observation Behavioral: Questionnaire Phase 3

Detailed Description:

Before treatment starts, patients will have a complete history (including details of previous chemotherapy, radiotherapy, and surgery for systemic disease). Patients will have a complete neuropsychological exam and will have their Karnofsky Performance Score (KPS) figured out. Seven cognitive function tests and a quality of life (QOL) questionnaire will be given to the patients as well. It will take about 40 minutes to complete the QOL questionnaire.

Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. Patients in one group will receive immediate whole brain radiation therapy. Patients in the other group will hold off on radiation and just be closely observed. There is an equal chance of being in either group.

All patients will receive radiosurgery treatment to the known metastases (1-3 lesions) at the beginning. All participants will be followed with serial diagnostic and functional MRI. Experimental functional imaging will be used to evaluate short-term memory and picture recognition as well as blood flow within the brain.

Formal neuropsychological testing will also be performed at each follow-up interval. Patients must come back at 4 months for neuropsychological testing. Patients will be seen for follow-up with neuropsychological evaluation, as well as diagnostic/function MRI at 1 , 2 , 4 , 6 , 9 , 12 , 15 , and 18 months and then every six months from then on. Each visit will require about 40 minutes of time.

Cost information related to protocol treatment and subsequent therapies will be tracked and collected for cost analysis between the two treatment groups.

Patients who did not receive whole brain radiation and develop recurrent disease shall receive treatment based on the number of lesions. If there are greater than 2 lesions, whole brain radiation will be given. If there are 1-2 lesions, patients will be randomly assigned to a local treatment (surgery or radiosurgery) or whole brain radiation therapy. Further recurrences in patients having not yet received whole brain radiation will be given this treatment at the time of recurrence.

The expected length of the study is 3.8 years with 6 months follow-up following the end of the study. Thus, the length of participation can range from 6 months for patients enrolling at the end of the study to over 4 years for patients enrolling at the beginning.

This is an investigational study. A total of 152 patients will take part in the study. All will be enrolled at MD Anderson.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Prospective Randomized Trial Comparing Radiosurgery With Versus Without Whole Brain Radiotherapy for 1-3 Newly Diagnosed Brain Metastases
Actual Study Start Date : January 2001
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Whole Brain Radiation Therapy
Whole Brain Radiation Therapy
Procedure: Whole Brain Radiation Therapy
Whole Brain Radiation Therapy. Total dose = 30 Gy over 12 fractions at 2.5Gy per fraction.
Other Name: WBRT

Behavioral: Questionnaire
Questionnaire taking 40 minutes to complete.
Other Name: Survey

Other: Observation
Patients who did not receive whole brain radiation and develop recurrent disease shall receive treatment based on the number of lesions.

Behavioral: Questionnaire
Questionnaire taking 40 minutes to complete.
Other Name: Survey

Primary Outcome Measures :
  1. Cognitive Decline [ Time Frame: 4 months ]
    Cognitive decline objectively measured by significant deterioration in HVLT-R LEARN at 4 months (i.e., a drop by at least 5 points compared to baseline). Difference between pretreatment baseline score and follow-up assessment scores determined by using the reliable change index (RCI).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

1)age 18 and older at time of registration. 2) recursive partitioning class (RPA) I or II. 3) 1 to 3 newly diagnosed brain metastases 4) must be eligible to have all lesions treated by SRS as determined by the radiation oncologist on the basis of location and size. 5)MRI with contrast must be performed with 1 month of registration. 6)Signed informed consent form approved by the IRB agreeing to randomization .

Exclusion Criteria:

1) prior WBRT 2) prior resection of brain metastasis, SRS or Gamma knife. 3) > 3 brain metastases present on MRI 4) lymphoma, small cell lung cancer, leukemia, germ cell tumors. 5) leptomeningeal disease. 6) unknown primary.7) RPA Class III (i.e. KPS < 70) 8) pregnancy.

Post-entry exclusion: No post-entry exclusions will be allowed after registration has occurred. All randomized patients will be included in the analysis and those lost to follow-up will be assigned the least favorable outcome (recurrence, death).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00548756

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: David L. Grosshans, MD,PHD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00548756     History of Changes
Other Study ID Numbers: ID00-377
NCI-2012-01590 ( Registry Identifier: NCI CTRP )
First Posted: October 24, 2007    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by M.D. Anderson Cancer Center:
Brain Cancer
Whole Brain Radiation Therapy
Quality of Life

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