Clinical trial NCT02622841: Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases
Official title: Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases: First-in-Man Study According to the IDEAL Recommendations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neoplasm Metastasis
Keywords: First in man
Spinal metastases
Stereotactic bodyradiotherapy
Palliative care
Safety
Surgical stabilisation
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the feasibility and safety of combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine.

Detailed description: Rationale: Sixty-five percent of cancer patients with terminal illness have bone metastases, with debilitating pain as devastating consequence. The spine is the most common location for bone metastases. Spinal cord compression is present in 10% of patients with vertebral metastases and aggravates pain and performance status even further. Standard treatment of unstable vertebral metastases consists of stabilizing surgery, followed by external beam radiotherapy (8 Gy) after two weeks. Although this approach is effective in 60-70% of patients, it is has several downsides. Firstly, because of the two weeks interval between surgery and external beam radiotherapy, necessary for sufficient wound healing, it takes a long time before radiotherapy induced pain relief is achieved. Scatter artifacts on planning computed tomography images caused by surgical implants prohibit high-resolution imaging and accurate targeting of the lesion. Multiple hospital visits (+/- 10) are needed for administration of external beam irradiation, and in about 30-40% of patients no adequate pain response is achieved. An alternative treatment strategy, which would lead to faster pain relief in a higher proportion of patients with less hospital visits, would be highly desirable from the patient's perspective.

Objective: To assess the feasibility and safety of combining stereotactic body radiotherapy (SBRT) and pedicle screw fixation in a 48-hour window for the treatment of painful unstable metastases of the thoracic and/or lumbar spine.

Study design: Prospective case series (13), first in man study, Phase I and II a study according to the IDEAL recommendations

Study population: All patients, male and female, with impending spinal stability requiring radiation therapy and surgical intervention at the University Medical Center Utrecht

Main study parameters/endpoints: The main outcome of this study is safety of the combined procedure, defined as grade 3 or higher treatment-induced toxicity according to common terminology criteria for adverse events (CTC-AE) 4.0 as a result of the procedure within 60 days after the surgery.

Eligibility criteria: Inclusion Criteria:

* Painful 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
* Written informed consent

Exclusion Criteria:

* Multiple spinal metastases necessitating bridging more than five vertebral levels during surgery
* Previous surgery or radiotherapy to index lesion
* stereotactic body radiotherapy cannot be delivered (Bilsky score 2 and 3)
* 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 stereotactic body radiotherapy
* Non-ambulatory patients
* Patient in hospice or with \< 3 months life expectancy
* Medically inoperable or patient refused surgery

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: first 90 days post treatment
Secondary outcomes:
measure: Pain response
timeFrame: first 90 days post treatment
measure: Duration of pain relief
timeFrame: first 90 days post treatment
measure: Rapidity of pain relief
timeFrame: first 90 days post treatment
measure: Hospital stay
timeFrame: first 90 days post treatment
measure: Early mortality
timeFrame: First 30 days post treatment
measure: Neurological status
timeFrame: First 90 days post treatment
measure: Quality of life
timeFrame: first 90 days post treatment
measure: Survival
timeFrame: Time from inclusion until date of death from any cause assessed up to 100 months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Jorrit-Jan Verlaan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: