Stereotactic body radiotherapy followed by surgical stabilization for patients with painful unstable spinal metastases: First-in-man study according to the IDEAL recommendations

Phase 2

Completed

Conditions: metastatic spine tumor
spinal metastases
10005959
10027476
10005944

Registration Number: NL-OMON42087

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 13

Inclusion Criteria

* Painful radiosensitive metastases from solid tumors in the thoracic or lumbar spine needing surgical stabilization
* Histologic proof of malignancy
* Radiographic evidence of spinal metastases
* Karnofsky performance status > 50
* Age > 18 years
* Written informed consent

Exclusion Criteria

* Multiple spinal metastases necessitating bridging more than five vertebral levels during surgery
* Previous surgery or radiotherapy to index lesion
* SBRT cannot be delivered (Bilsky score 2 and 3 [Bilsky 2010])
* Neurological deficits (ASIA C, B or A)
* Partial neurological deficits (ASIA D) with rapid progression (hours to days)
* Inability to lie flat on table for SBRT
* Non-ambulatory patients
* Patient in hospice or with < 3 months life expectancy
* Medically inoperable or patient refused surgery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome of this study is safety of the combined procedure, defined as<br /><br>grade 3 or higher treatment-induced toxicity according to CTC-AE 4.0 as a<br /><br>result of the procedure within 60 days after the surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study endpoints of this study are:<br /><br><br /><br>* Pain response to combined therapy according to the International Bone<br /><br>Metastases Consensus Endpoints for Clinical Trials (Chow 2002; Chow 2012b)<br /><br>* Duration of pain relief, as measured by the Brief Pain Inventory (BPI)<br /><br>(Cleeland 1994)<br /><br>* Length of stay in the hospital<br /><br>* 30-days mortality<br /><br>* Neurological detoriation, defined as detoriation of more than one ASIA scale<br /><br>* Evaluation of quality of life, as measured by the<br /><br>o EQ-5D<br /><br>o EORTC QLQ-C15-PAL<br /><br>o EORTC QLQ-BM22<br /><br>o Spine Oncology Questionnaire<br /><br>* Overall survival</p><br>