Neurology · 2004 · 355 citations · 8 references
MedicineOncologyRadiation OncologyNeuro-oncologyNeuroradiologyTumor ProgressionBrain TumorsGlioma RadiotherapyMagnetic Resonance ImagingNeuro-oncology Clinical TrialsRadiation TherapyRecurrent Brain TumorsGlioblastoma Clinical TrialsNeuroimaging Response AssessmentPhase Ii Clinical TrialsPhase Ii Oncology TrialsPhase Iii Clinical TrialsRadiotherapy TrialsTumor Progression After Therapy
To determine the frequency of progressive MRI lesions shortly after radiotherapy for glioma with spontaneous improvement or stabilization, the authors studied a cohort of patients treated within two prospective phase III trials with radiotherapy only. In 9 out of 32 patients, the first post-radiotherapy MRI showed progressive enhancement. In 3 of these 9 the MRI improved or stabilized for 6 months without additional treatment. The authors conclude that patients with progressive lesions within 3 months after radiotherapy should not be eligible for phase II trials on recurrent glioma.
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Optimal two-stage designs for phase II clinical trials
Richard Simon · Controlled Clinical Trials · 1989 · 3.6K citations
Response criteria for phase II studies of supratentorial malignant glioma.
David R. Macdonald, T L Cascino, S. Clifford Schold et al. · Journal of Clinical Oncology · 1990 · 2.4K citations