Treatment for limited spine metastases after surgery

Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy

This study is testing whether a new type of targeted radiation therapy works better than regular radiation for people who have had surgery for limited spine cancer that has spread from other solid tumors.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 111 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (other)
• Locations: 1 site (Taipei)
• Trial ID: NCT05495399 on ClinicalTrials.gov

What this trial studies

This study evaluates patients with limited spine metastases who undergo total spondylectomy followed by either conventional radiotherapy or stereotactic body radiotherapy (SBRT). The primary goal is to assess local control of the disease one year after treatment. Eligible patients must have pathologically confirmed solid cancers and specific criteria regarding the extent of their spine metastases. The study aims to determine the effectiveness of these surgical and radiotherapy approaches in managing spine metastases.

Who should consider this trial

Good fit: Ideal candidates are patients aged 20 and older with pathologically confirmed solid cancers and limited spine metastases suitable for surgery.

Not a fit: Patients who have received prior radiotherapy to the affected spine levels are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve local control of spine metastases, potentially leading to better patient outcomes.

How similar studies have performed: While there is ongoing research in this area, the specific combination of spondylectomy followed by SBRT or conventional RT for limited spine metastases is a relatively novel approach.

Eligibility criteria

Inclusion Criteria:

1. Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.
2. Patients with maximum two continuous level of spine metastases need for surgery are eligible. Patients who have other spine metastases but not necessary for surgery are allowed.
3. A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.
4. Patients aged at least 20 years old are eligible.
5. Life expectancy of ≥ 6 months.
6. ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment)
7. No prior RT to the index spine level(s)
8. Women of childbearing potential must practice adequate contraception
9. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.

Exclusion Criteria:

1. Patients received prior radiotherapy to the index spine level.
2. Patients who cannot receive Gadolinium enhanced MRI due to pacemaker or metal implant or who cannot receive contrast enhanced CT scan due to impaired renal function.
3. Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
4. Patients who cannot tolerate radiotherapy immobilization.
5. Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:

   1. Uncontrolled active infection requiring intravenous antibiotics at the time of registration
   2. Transmural myocardial infarction ≤ 6 months prior to registration.
   3. Life-threatening uncontrolled clinically significant cardiac arrhythmias.
   4. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
   5. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
   6. Uncontrolled psychiatric disorder.
6. Pregnant or breast-feeding women

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Wen Chi Yang

Conditions: Spine Metastases, Stereotactic body radiotherapy, Spondylectomy, Separation surgery