Postoperative Radiotherapy for Single Brain Metastases

To the Editor: Dr Patchell and colleagues¹ randomized patients to postoperative radiation therapy or observation after surgical resection of single brain metastases. Considering that radiation therapy would be the conventional approach for a patient off study, it seems that this study would be difficult to accomplish. This raises several questions. First, what was the authors' experience in obtaining institutional review board (IRB) approval, and did they and the participating institutions encounter difficulties at this level? An informal discussion among my colleagues indicates that this study would have difficulty receiving IRB approval at our institution. Second, did the authors consider randomizing patients to different schedules of radiation therapy, and if the lower schedule was as effective as a standard dose, then proceeding with the no-treatment arm study? Third, what was the total number of all eligible patients at all participating institutions referred to in the study design (which included "University of Kentucky, Lexington, and . . . the other individual institutions that participated in the trial through the Southwest Oncology Group, the Radiation Therapy Oncology Group, and the Brain Tumor Cooperative Group")?