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

Phase 3

Active, not recruiting

• Conditions: Metastatic Malignant Neoplasm; Metastatic Malignant Neoplasm in the Brain

• Registration Number: NCT01592968
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-5-3
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Inclusion Criteria:<br><br> - All patients must have histological proof of malignant cancer, which is metastatic.<br> Histological proof may be obtained from the primary tumor or another metastatic<br> site. However, cytology alone is not an acceptable method of diagnosis.<br><br> - All patients must have greater than 3 but less than or equal to 15 metastatic<br> lesions seen on a contrast enhancing MRI scan obtained not less than one month prior<br> to study enrollment. Patients who are found to have up to 20 metastatic lesions at<br> the time of treatment planning (on volumetric MRI once the head frame is in place)<br> may still participate in the trial.<br><br> - All patients must be >/= 18 years of age.<br><br> - All patients must sign informed consent verifying that they are aware of the<br> investigational nature of this study in keeping with the rules and policies of M.D.<br> Anderson Cancer Center. The only acceptable consent form is the one attached at the<br> end of this protocol, and it must have been approved and amended by the M.D.<br> Anderson IRB.<br><br> - All patients must be eligible to have all lesions treated with SRS (i.e. maximum<br> diameter of largest lesion < 3.5cm) as determined by the radiation oncologist .<br><br> - All patients must have adequate liver, renal, and hematologic function as defined by<br> Aspartate Amino Transferase (AST)/Alanine Amino Transferase (ALT)/Alkaline<br> Phosphatase < 2.5 times normal, calculated creatinine clearance > 30ml/min, and<br> platelet count > 50,000.<br><br> - All patients should have normal coagulation, with international normalized ratio<br> (INR) < 1.3 and able to withhold anti-coagulation medications a minimum of 24 hours<br> prior to radiosurgery (or until INR normalizes), on the day of treatment and 24<br> hours after radiosurgery has concluded. Those patients getting WBRT may continue<br> these medications.<br><br> - Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the<br> discretion of their treating oncologist.<br><br>Exclusion Criteria:<br><br> - Patients are excluded from this trial if they have melanoma, small cell carcinoma,<br> lymphoma/leukemia, or germ cell histology (note, melanoma patients will be eligible<br> for the sister trial to this trial which will be open simultaneously).<br><br> - Patients will be excluded if they have had prior surgical resection of metastatic<br> cancer from the brain.<br><br> - Patients will be excluded if there is radiographic or CSF cytological evidence of<br> leptomenengial disease.<br><br> - Patients will be excluded if they have had prior Whole Brain Radiotherapy (WBRT) or<br> prophylactic cranial irradiation (PCI). Prior SRS or Gamma Knife radiosurgery to 1-3<br> metastases with minimum of (6) weeks to the most recent scan are allowed on<br> protocol.<br><br> - Female patients of childbearing age will be excluded if they are pregnant as<br> assessed by serum b-HCG or urine pregnancy test. A serum b-HCG test or urine<br> pregnancy test will be performed no greater than 14 days prior to study<br> registration.<br><br> - Patients will be excluded if they are unable to obtain an MRI scan.<br><br> - Patients will be excluded if they have < 4 lesions, or > 15 lesions at enrollment or<br> > 20 lesions at the time of treatment (note: patients who qualify for enrollment<br> based on having 4-15 lesions, but who are discovered to have up to 20 lesions on the<br> volumetric MRI used for treatment planning will be allowed to continue on study).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Local control rate;Proportion of patients with neurocognitive decline

Secondary Outcome Measures

Name	Time	Method
Time to local failure;Cumulative incidence of local failure;Time to neurocognitive decline;Cumulative incidence of neurocognitive decline