Stereotactic Body Radiotherapy Followed by Surgical Stabilization in Spinal Metastases

NCT05060653 | Withdrawn DMC

• 1 other identifier: NL76750.041.21
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess pain response after 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.

Conditions

Spinal Neoplasms; Neoplasm Metastasis; Radiosurgery; Surgery

Outcome Measures

Primary Outcomes (1)

• Pain response

  Pain response is defined as a decrease in initial worst pain score by at least 2 points on a Numeric Rating Scale (NRS) of 10 at the treated site, without increase in analgesic use, or an analgesic decrease of at least 25% without an increase in pain score

  4 weeks

Secondary Outcomes (6)

• Duration of pain relief

  Through hospital stay, an average of 3 days

• Length of hospital stay

  Through hospital stay, an average of 3 days

• 30-day mortality

  30 days

• Neurological status

  Through hospital stay, an average of 3 days

• Neurological deterioration

  Through hospital stay, an average of 3 days

Study Arms (1)

SBRT followed by surgical stabilization within 48 hours

EXPERIMENTAL

SBRT and surgical stabilization will be performed within a 24 to 48-hour time window instead of today's standard of care of two weeks between surgical stabilization and conventional radiotherapy.

Other: SBRT followed by surgical stabilization within 24-48 hours

Interventions

SBRT followed by surgical stabilization within 24-48 hours OTHER

In a first step, patients will undergo SBRT with active sparing of the surgical site. Patients will receive high dose, single to few fractions radiotherapy consisting of a boost to the metastases exclusively. The bony compartment containing the metastatic lesion will receive an elective dose in order to treat subclinical disease. Treatment planning is performed on the pre-treatment CT and MRI data in radiotherapy position that are mutually registered to yield information on all relevant structures for planning. Dose constraints are set for the organ at risks based on institution specific guidelines. All patients will be treated with on online position verification protocol based on institution specific guidelines. Hereafter, surgical intervention will be performed to the standard of care.

SBRT followed by surgical stabilization within 48 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in PRESENT cohort
• Painful radiosensitive metastases from solid tumors in the cervical, thoracic or lumbar spine needing surgical stabilization
• Histologic proof of malignancy or radiographic/clinical characteristics indicating malignancy beyond reasonable doubt
• Radiographic evidence of spinal metastases
• Fit for (radio)surgery
• Age \> 18 years at the time of given informed consent in the PRESENT cohort.
• Written informed consent

You may not qualify if:

• SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain
• Surgery cannot be performed, e.g. in patients with multiple spinal metastases that cannot be bridged
• Previous surgery or radiotherapy to index lesion
• Neurological deficits (ASIA C, B or A)
• Partial neurological deficits (ASIA D) with rapid progression (hours to days)
• Non-ambulatory patients
• Patient in hospice or with \< 3 months life expectancy
• Medically inoperable or patient refused surgery
• Radiosensitizing systemic treatment that cannot reasonably be stopped (for example immunotherapy and EGFR inhibitors)

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Spinal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jorrit-Jan Verlaan, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: September 29, 2021
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)