Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases

Neoplasm Metastasis Clinical Trial

— BLEND  

Official title:

Stereotactic Body Radiotherapy Followed by Surgical Stabilization for Patients With Unstable Spinal Metastases: First-in-Man Study According to the IDEAL Recommendations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622841
• Other study ID #: NL51405.041.15
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 17, 2015
• Last updated: May 5, 2017
• Start date: June 2015
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Procedure:
• BLEND
Stereotactic bodyradiotherapy and surgical stabilization within 48 hours.

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events	Occurrence of adverse events grade 3/4 according to the common terminology criteria for adverse events (CTCAE) 4.0	first 90 days post treatment
Secondary	Pain response	Measurement of pain response to combined therapy according to consensus guidelines	first 90 days post treatment
Secondary	Duration of pain relief	Measurement of duration of pain relief	first 90 days post treatment
Secondary	Rapidity of pain relief	Measurement of rapidity of pain relief	first 90 days post treatment
Secondary	Hospital stay	Measurement of length of hospital stay	first 90 days post treatment
Secondary	Early mortality	Measurement of 30 days mortality	First 30 days post treatment
Secondary	Neurological status	Measurement of neurological deterioration	First 90 days post treatment
Secondary	Quality of life	Evaluation of quality of life	first 90 days post treatment
Secondary	Survival	Overall survival	Time from inclusion until date of death from any cause assessed up to 100 months