High-precision radiotherapy of motor deficits due to metastatic spinal cord compression (PRE-MODE): a multicenter phase 2 study

BMC Cancer

Study Protocol

Denise Olbrich¹  Niels Henrik Holländer²  Jürgen Dunst³  Antonio J. Conde-Moreno⁴  Jon Cacicedo⁵  Claudia Doemer⁶  Dirk Rades⁶  Barbara Segedin⁷  Darejan Lomidze⁸ 

[1] Centre for Clinical Trials Lübeck, Lübeck, Germany;Department of Oncology, Zealand University Hospital, Naestved, Denmark;Department of Radiation Oncology, Christian-Albrechts University Kiel, Kiel, Germany;Department of Radiation Oncology, Consorcio Hospital Provincial de Castellón, Castellón, Spain;Department of Radiation Oncology, Cruces University Hospital, Barakaldo, Vizcaya, Spain;Department of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, D-23562, Lübeck, Germany;Department of Radiotherapy, Institute of Oncology Ljubljana, Ljubljana, Slovenia;Radiation Oncology Department, High Technology Medical Center, University Clinic Tbilisi, Tbilisi, Georgia;

关键词: Metastatic spinal cord compression;    Volumetric modulated arc therapy;    Stereotactic body radiotherapy;    Local progression-free survival;    Motor function;    Overall survival;    Pain;    Quality of life;   

DOI  :  10.1186/s12885-017-3844-x

 received in 2017-08-03, accepted in 2017-11-24,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundFor metastatic spinal cord compression (MSCC), conventional radiotherapy with 10 × 3 Gy in 2 weeks results in better local progression-free survival (LPFS) than 5 × 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 × 5 Gy in 1 week, since the biologically effective dose is similar to 10 × 3 Gy. It can be expected that 5 × 5 Gy (like 10 × 3) Gy results in better LPFS than 5 × 4 Gy in 1 week.Methods/DesignThis phase 2 study investigates LPFS after high-precision RT with 5 × 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 × 5 Gy can be safely administered with high-precision radiotherapy such as volumetric modulated arc therapy (VMAT) 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 × 4 Gy in 1 week. Forty-four patients will be included assuming 5 × 5 Gy will provide the same benefit in LPFS when compared to 5 × 4 Gy as reported for 10 × 3 Gy.DiscussionIf superiority regarding LPFS is shown for high-precision radiotherapy with 5 × 5 Gy when compared to conventional radiotherapy with 5 × 4 Gy, patients with MSCC would benefit from 5 × 5 Gy, since high LPFS rates could be achieved with 1 week of radiotherapy instead of 2 weeks (10 × 3 Gy).Trial registrationclinicaltrials.gov NCT03070431. Registered 27 February 2017.

【 授权许可】

CC BY   
© The Author(s). 2017