Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2027-06-30

Brief Summary

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The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgical stabilization with or without decompression for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of treatment, compared with the standard of care (surgery followed by radiotherapy as soon as the wound healed sufficiently).

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Detailed Description

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Rationale: Currently, patients with unstable spinal metastases receive surgical stabilization with/without decompression followed by conventional radiotherapy (cRT) or stereotactic body radiotherapy (SBRT) as soon as wound healing allows (at least 1 week). Advancements in radiotherapy techniques makes preoperative radiotherapy possible with sparing of the soft tissues overlying the surgical field. This makes it possible to shorten or even eliminate the time interval between surgery and radiotherapy. This will result in shorter and less hospital visits, earlier pain relief from irradiation, and faster return to systemic therapy without an increase in wound complications due to the short interval between surgery and radiotherapy.

Objective: The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgery for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of the treatment, compared with the standard of care (surgery followed by radiotherapy, i.e., CRT or SBRT).

Study design: A phase II randomized controlled trial within the PRospective Evaluation of interventional StudiEs on boNe metastases (PRESENT) cohort including patients with bone metastases, according to the Trials within Cohorts (TwiCs) design.

Study population: Patients with symptomatic (cervical, thoracic and/or lumbar) spinal metastases and impending spinal instability requiring radiotherapy and surgical stabilization with or without decompression.

Intervention: SBRT (with active dose-sparing of the surgical site) and surgical stabilization with or without decompression within 24 hours. The control group will receive the standard of care, which is surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently.

Main study endpoints: The primary endpoint is physical functioning at four weeks after the start of the treatment. Secondary endpoints are pain response, duration of pain relief, length of hospital stay, time to return to systemic therapy, neurological deterioration, adverse events (e.g. wound complications), quality of life and survival. In addition, we will study the cost-effectiveness.

Conditions

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Spinal Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

According to the TwiCs design, patients allocated to the control group are not informed about their role as a control in the trial.

Study Groups

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Intervention

Patients will receive high dose, single fraction stereotactic body radiotherapy (SBRT) using differential dosing: 18 or 21 Gy on the metastasis. Within 24 hours after SBRT, patients will have surgical stabilization with or without decompression.

Group Type EXPERIMENTAL

Same-day SBRT and spinal surgery

Intervention Type OTHER

SBRT and surgical stabilization with or without decompression within 24 hours

Control

Patients will undergo the standard of care, which is surgical stabilization with or without decompression, followed by conventional radiotherapy (cRT) or SBRT as soon as the wound is healed sufficiently.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently

Interventions

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Same-day SBRT and spinal surgery

SBRT and surgical stabilization with or without decompression within 24 hours

Intervention Type OTHER

Standard of care

Surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Symptomatic (cervical, thoracic and/or lumbar) spinal metastases from solid tumors and (impending) spinal instability requiring radiotherapy and surgical decompression and/or stabilization
* Histologic proof of malignancy or radiographic/clinical characteristics indicating malignancy beyond reasonable doubt
* Radiographic evidence of spinal metastases
* Participation in PRESENT cohort, including consent for randomization into future trials
* Fit for (radio)surgery
* Age \>18 years
* Written informed consent

Exclusion Criteria

* SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain
* Routine surgical decompression and/or stabilization and radiotherapy cannot be performed, e.g., multiple spinal metastases requiring surgical bridging of more than five vertebral levels and/or requiring radiotherapy on more than one location
* Prior surgery or radiotherapy to the index level(s)
* Multiple myeloma
* Neurological deficits (ASIA C, B or A), or partial neurological deficits (ASIA D) with rapid progression (hours to days)
* Treated with Bevacizumab and other medication with long half-life that interferes with radiotherapy
* Life expectancy of less than 3 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No