TY - JOUR

T1 - Stereotactic radiosurgery versus decompressive surgery followed by postoperative radiotherapy for metastatic spinal cord compression (STEREOCORD)

T2 - Study protocol of a randomized non-inferiority trial

AU - Suppli, Morten H

AU - Af Rosenschold, Per Munck

AU - Pappot, Helle

AU - Dahl, Benny

AU - Morgen, Søren S

AU - Vogelius, Ivan R

AU - Engelholm, Svend A

PY - 2016

Y1 - 2016

N2 - Current treatment standard for patients with metastatic spinal cord compression (MSCC) is decompressive surgery followed by radiotherapy. Stereotactic radiosurgery (SRS) could be considered a treatment option for MSCC for patients with minor neurologic deficits. If SRS is safely and effectively delivered with equivalent functional outcome, the patients would avoid the risks associated with an invasive procedure. This paper presents the design of a non-inferiority clinical trial evaluating the safety, tolerability and feasibility of SRS vs. current standard treatment for patients with MSCC. Patients fulfilling inclusion criteria will be randomized 1:1 to each arm. The primary endpoint is ability to walk six weeks after treatment. Secondary endpoints are levels of pain, bladder control, quality of life, response rate, toxicity and number of treatment days. 65 patients in each arm are required for the power of 89% to detect a clinically relevant inferior outcome.

AB - Current treatment standard for patients with metastatic spinal cord compression (MSCC) is decompressive surgery followed by radiotherapy. Stereotactic radiosurgery (SRS) could be considered a treatment option for MSCC for patients with minor neurologic deficits. If SRS is safely and effectively delivered with equivalent functional outcome, the patients would avoid the risks associated with an invasive procedure. This paper presents the design of a non-inferiority clinical trial evaluating the safety, tolerability and feasibility of SRS vs. current standard treatment for patients with MSCC. Patients fulfilling inclusion criteria will be randomized 1:1 to each arm. The primary endpoint is ability to walk six weeks after treatment. Secondary endpoints are levels of pain, bladder control, quality of life, response rate, toxicity and number of treatment days. 65 patients in each arm are required for the power of 89% to detect a clinically relevant inferior outcome.

M3 - Journal article

C2 - 29296431

VL - 4

SP - S1-S9

JO - Journal of Radiosurgery and SBRT

JF - Journal of Radiosurgery and SBRT

SN - 2156-4639

IS - 1

ER -