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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42087

Enrollment

Registered

2015-02-05

Start date

2015-06-03

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic spine tumor spinal metastases

Interventions

Shortened time window Stereotactic body radiotherapy and surgical stabilization will be performed within a 48-hour time window instead of today*s standard of care of two weeks between surgical stabi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The main outcome of this study is safety of the combined procedure, defined as grade 3 or higher treatment-induced toxicity according to CTC-AE 4.0 as a result of the procedure within 60 days after the surgery.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)