High-precision radiotherapy of motor deficits due to metastatic spinal cord compression (PRE-MODE): a multicenter phase 2 study
Por:
Rades D, Cacicedo J, Conde-Moreno AJ, Doemer C, Dunst J, Lomidze D, Segedin B, Olbrich D, Holländer NH
Publicada:
4 dic 2017
Resumen:
Background: For metastatic spinal cord compression (MSCC), conventional radiotherapy with 10 x 3 Gy in 2 weeks results in better local progression-free survival (LPFS) than 5 x 4 Gy in 1 week. Since patients with MSCC are often significantly impaired, an overall treatment time of 1 week would be preferable if resulting in similar outcomes as longer programs. This may be achieved with 5 x 5 Gy in 1 week, since the biologically effective dose is similar to 10 x 3 Gy. It can be expected that 5 x 5 Gy (like 10 x 3) Gy results in better LPFS than 5 x 4 Gy in 1 week.
Methods/Design: This phase 2 study investigates LPFS after high-precision RT with 5 x 5 Gy in 1 week. LPFS is defined as freedom from both progression of motor deficits during RT and new or progressive motor deficits dur to an in-field recurrence of MSCC following RT. Considering the tolerance dose of the spinal cord, 5 x 5 Gy can be safely administered with high-precision radiotherapy such as volumetric modulated arc therapy (MAT) or stereotactic body radiotherapy (SBRT). Maximum dose to the spinal cord should not exceed 101.5% of the prescribed dose to keep the risk of radiation myelopathy below 0.03%. Primary endpoint is LPFS at 6 months following radiotherapy; secondary endpoints include motor function/ability to walk, sensory function, sphincter dysfunction, LPFS directly and 1 and 3 months following radiotherapy, overall survival, pain relief, quality of life and toxicity. Follow-up visits will be performed directly and at 1, 3 and 6 months following radiotherapy. After completion of this phase 2 study, patients will be compared to a historical control group receiving conventional radiotherapy with 5 x 4 Gy in 1 week. Forty-four patients will be included assuming 5 x 5 Gy will provide the same benefit in LPFS when compared to 5 x 4 Gy as reported for 10 x 3 Gy.
Discussion: If superiority regarding LPFS is shown for high-precision radiotherapy with 5 x 5 Gy when compared to conventional radiotherapy with 5 x 4 Gy, patients with MSCC would benefit from 5 x 5 Gy, since high LPFS rates could be achieved with 1 week of radiotherapy instead of 2 weeks (10 x 3 Gy).
Filiaciones:
Rades D:
Department of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, D-23562, Lübeck, Germany.
Cacicedo J:
Department of Radiation Oncology, Cruces University Hospital, Barakaldo, Vizcaya, Spain
Conde-Moreno AJ:
Department of Radiation Oncology, Consorcio Hospital Provincial de Castellón, Castellón, Spain
Doemer C:
Department of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, D-23562, Lübeck, Germany
Dunst J:
Department of Radiation Oncology, Christian-Albrechts University Kiel, Kiel, Germany
Lomidze D:
Radiation Oncology Department, High Technology Medical Center, University Clinic Tbilisi, Tbilisi, Georgia
Segedin B:
Department of Radiotherapy, Institute of Oncology Ljubljana, Ljubljana, Slovenia
Olbrich D:
Centre for Clinical Trials Lübeck, Lübeck, Germany
Holländer NH:
Department of Oncology, Zealand University Hospital, Naestved, Denmark
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