Post Operative RT for Limited Spine Metastases

Recruiting now · Not applicable

Conditions studied: Spine Metastases

In brief

To evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by SBRT or conventional RT. The study primary endpoint is one year local control.

Key facts

Study ID

NCT05495399

Run by

National Taiwan University Hospital

People needed

111

Starts

2022-08-01

Expected to finish

2027-07-01

Last updated by the study team

2024-02-06

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.
• 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.
• A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.
• Patients aged at least 20 years old are eligible.
• Life expectancy of ≥ 6 months.
• ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment)
• No prior RT to the index spine level(s)
• Women of childbearing potential must practice adequate contraception
• Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.

You may not qualify if…

• Patients received prior radiotherapy to the index spine level.
• 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.
• Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
• Patients who cannot tolerate radiotherapy immobilization.
• 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:
• Uncontrolled active infection requiring intravenous antibiotics at the time of registration
• Transmural myocardial infarction ≤ 6 months prior to registration.
• Life-threatening uncontrolled clinically significant cardiac arrhythmias.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
• Uncontrolled psychiatric disorder.
• Pregnant or breast-feeding women

Where it is running

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

Full record on ClinicalTrials.gov

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