Post Operative RT for Limited Spine Metastases

Not Applicable

Recruiting

• Conditions: Spine Metastases
• Interventions: Procedure: Spondylectomy; Radiation: SBRT

• Registration Number: NCT05495399
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-06
• Primary Completion: 2026-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 111

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spondylectomy with Conventional RT	Spondylectomy	Spondylectomy for involved spine level followed by conventional RT 20Gy in 5 fractions
Debulking surgery with Conventional RT	Spondylectomy	Debulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions
Debulking surgery with SBRT	SBRT	Debulking surgery for involved spine level followed by SBRT 24Gy in 12 fractions
Debulking surgery with Conventional RT	SBRT	Debulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions

Primary Outcome Measures

Name	Time	Method
Local control	12 months post surgery	Number of patients with locally controlled disease of index spine after intervention

Secondary Outcome Measures

Name	Time	Method
Treatment related toxicity	Every 3 months up to 1 year post surgery	Using Common Terminology Criteria for Adverse Events
Overall survival	12 months post surgery	Survival from treatment to death
pain control	Every 3 months up to 1 year post surgery	using numerical pain score to assess pain
Quality of life assessment	Every 3 months up to 1 year post surgery	EORTC QLQ-BM22

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan