Post Operative RT for Limited Spine Metastases

National Taiwan University

Status: Enrolling

Conditions: Spine Metastases

Treatments: Radiation: SBRT; Procedure: Spondylectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05495399

202204039RINA

Details and patient eligibility

About

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.

Enrollment: 111 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 3 patient groups

Spondylectomy with Conventional RT

Experimental group

Description:

Spondylectomy for involved spine level followed by conventional RT 20Gy in 5 fractions

Treatment:

Procedure: Spondylectomy

Debulking surgery with Conventional RT

Active Comparator group

Description:

Debulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions

Treatment:

Radiation: SBRT

Procedure: Spondylectomy

Debulking surgery with SBRT

Experimental group

Description:

Debulking surgery for involved spine level followed by SBRT 24Gy in 12 fractions

Treatment:

Radiation: SBRT