Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Treating Patients With Newly Diagnosed Non-melanoma Brain Metastases

NCT01592968 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 2011-0884NCI-2014-02058NCI-2012-00850
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase III clinical trial compares stereotactic radiosurgery with whole brain radiation therapy to see how well they work in treating patients with non-melanoma cancer that has recently spread from the first location to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized type of radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Whole brain radiation therapy delivers a lower dose of radiation to the entire brain over several treatments. It is not yet known whether stereotactic radiosurgery works better than whole brain radiation therapy in treating patients with non-melanoma brain metastases. Stereotactic radiosurgery may also cause fewer thinking and memory problems than whole brain radiation therapy.

Conditions

Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• Local control rate

  Estimated for each treatment arm with 95% confidence intervals based on the estimates of time to local failure.

  At 4 months

• Proportion of patients with neurocognitive decline

  Defined as a decline of 5 or more points from baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) score. Estimated for each treatment arm with 95% confidence intervals based on the estimates of time to neurocognitive decline.

  At 4 months

Secondary Outcomes (4)

• Time to local failure

  Up to 12 months

• Cumulative incidence of local failure

  Up to 12 months

• Time to neurocognitive decline

  Up to 12 months

• Cumulative incidence of neurocognitive decline

  Up to 12 months

Study Arms (2)

Arm I (SRS)

EXPERIMENTAL

Patients undergo SRS on day 1.

Other: Cognitive Assessment; Other: Quality-of-Life Assessment; Radiation: Stereotactic Radiosurgery

Arm II (WBRT)

EXPERIMENTAL

Patients undergo WBRT 5 days per week (7 days per week for inpatients) for 2 weeks.

Other: Cognitive Assessment; Other: Quality-of-Life Assessment; Radiation: Whole-Brain Radiotherapy

Interventions

Stereotactic Radiosurgery RADIATION

Undergo SRS

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Arm I (SRS)

Whole-Brain Radiotherapy RADIATION

Undergo WBRT

Also known as: WBRT, whole-brain radiation therapy

Arm II (WBRT)

Cognitive Assessment OTHER

Ancillary studies

Arm I (SRS); Arm II (WBRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (SRS); Arm II (WBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• All patients must have greater than 3 but less than or equal to 15 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 up to 20 metastatic lesions at the time of treatment planning (on volumetric MRI once the head frame is in place) may still participate in the trial.
• All patients must be \>/= 18 years of age.
• 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.
• 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 .
• 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.
• 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.
• Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist.

You may not qualify if:

• 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).
• Patients will be excluded if they have had prior surgical resection of metastatic cancer from the brain.
• Patients will be excluded if there is radiographic or CSF cytological evidence of leptomenengial disease.
• Patients will be excluded if they have had prior Whole Brain Radiotherapy (WBRT) or prophylactic cranial irradiation (PCI). Prior SRS or Gamma Knife radiosurgery to 1-3 metastases with minimum of (6) weeks to the most recent scan are allowed on protocol.
• 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.
• Patients will be excluded if they are unable to obtain an MRI scan.
• Patients will be excluded if they have \< 4 lesions, or \> 15 lesions at enrollment or \> 20 lesions at the time of treatment (note: patients who qualify for enrollment based on having 4-15 lesions, but who are discovered to have up to 20 lesions on the volumetric MRI used for treatment planning will be allowed to continue on study).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

Mental Status and Dementia Tests; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jing Li

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: August 2, 2012
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)