NCT01592968

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

Active, enrolled Phase 3 Last updated 9 March 2026

What this trial tests

Phase 3 trial testing Cognitive Assessment in Metastatic Malignant Neoplasm in 88 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

2 August 2012

Primary endpoint
30 September 2027

30 September 2027

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	88
Start date	2 August 2012
Primary completion	30 September 2027
Estimated completion	30 September 2027
Sites	1 location across United States

Drugs / interventions tested

• Cognitive Assessment
• Quality-of-Life Assessment
• Stereotactic Radiosurgery
• Whole-Brain Radiotherapy

Conditions studied

• Metastatic Malignant Neoplasm — all drugs for Metastatic Malignant Neoplasm →
• Metastatic Malignant Neoplasm in the Brain — all drugs for Metastatic Malignant Neoplasm in the Brain →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Metastatic Malignant Neoplasm or Metastatic Malignant Neoplasm in the Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Whole-Brain Radiotherapy for Brain Metastases: Evolution or Revolution?
   Brown PD, Ahluwalia MS, Khan OH, Asher AL, et al · · 2018 · cited 160× · PMID 29272161 · DOI 10.1200/jco.2017.75.9589
2. Radiation-induced cognitive toxicity: pathophysiology and interventions to reduce toxicity in adults.
   Wilke C, Grosshans D, Duman J, Brown P, et al · · 2018 · cited 80× · PMID 29045710 · DOI 10.1093/neuonc/nox195
3. Stereotactic radiosurgery alone for multiple brain metastases? A review of clinical and technical issues.
   Sahgal A, Ruschin M, Ma L, Verbakel W, et al · · 2017 · cited 74× · PMID 28380635 · DOI 10.1093/neuonc/nox001
4. Breast Cancer Brain Metastasis-Overview of Disease State, Treatment Options and Future Perspectives.
   Watase C, Shiino S, Shimoi T, Noguchi E, et al · · 2021 · cited 68× · PMID 33802424 · DOI 10.3390/cancers13051078
5. Stereotactic Radiosurgery in the Management of Patients With Brain Metastases of Non-Small Cell Lung Cancer: Indications, Decision Tools and Future Directions.
   Hartgerink D, van der Heijden B, De Ruysscher D, Postma A, et al · · 2018 · cited 43× · PMID 29868476 · DOI 10.3389/fonc.2018.00154
6. The growing importance of lesion volume as a prognostic factor in patients with multiple brain metastases treated with stereotactic radiosurgery.
   Routman DM, Bian SX, Diao K, Liu JL, et al · · 2018 · cited 42× · PMID 29441722 · DOI 10.1002/cam4.1352
7. Brain metastases: An update on the multi-disciplinary approach of clinical management.
   Mitchell DK, Kwon HJ, Kubica PA, Huff WX, et al · · 2022 · cited 39× · PMID 33864773 · DOI 10.1016/j.neuchi.2021.04.001
8. Whole Brain Irradiation or Stereotactic RadioSurgery for five or more brain metastases (WHOBI-STER): A prospective comparative study of neurocognitive outcomes, level of autonomy in daily activities and quality of life.
   Ferini G, Viola A, Valenti V, Tripoli A, et al · · 2022 · cited 30× · PMID 34926839 · DOI 10.1016/j.ctro.2021.11.008