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

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

NCT ID: NCT05575323

Condition: Spinal Metastases

Conditions: Official terms:
Neoplasm Metastasis

Conditions: Keywords:
Spinal metastases
SBRT
Surgery
Same-day treatment
RCT

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

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

Intervention:

Intervention type: Other
Intervention name: Same-day SBRT and spinal surgery
Description: SBRT and surgical stabilization with or without decompression within 24 hours
Arm group label: Intervention

Intervention type: Other
Intervention name: Standard of care
Description: Surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently
Arm group label: Control

Summary: 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).

Detailed description: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Medical Center Utrecht

Address:
City: Utrecht
Country: Netherlands

Status: Recruiting

Contact:
Last name: Helena M. Verkooijen, MD, PhD
Email: H.M.Verkooijen@umcutrecht.nl

Investigator:
Last name: Roxanne Gal, PhD
Email: Sub-Investigator

Investigator:
Last name: Helena M. Verkooijen, MD, PhD
Email: Principal Investigator

Start date: October 15, 2022

Completion date: June 30, 2027

Lead sponsor:
Agency: UMC Utrecht
Agency class: Other

Collaborator:
Agency: Radboud University Medical Center
Agency class: Other

Source: UMC Utrecht

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05575323