Post Operative RT for Limited Spine Metastases

Spine Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495399
• Other study ID #: 202204039RINA
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 2027

Study information

• Verified date: February 2024
• Source: National Taiwan University Hospital
• Contact: Wen Chi Yang
• Phone: +886223123456
• Email: claireds23[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: July 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spine Metastases

Intervention

Procedure:
• Spondylectomy
Patient will be randomized to treated by spondylectomy or debulking surgery. Spondylectomy implied total resection of involved spine; while debulking surgery means partial resection of involved spine.

Radiation:
• SBRT
Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control	Number of patients with locally controlled disease of index spine after intervention	12 months post surgery
Secondary	Overall survival	Survival from treatment to death	12 months post surgery
Secondary	pain control	using numerical pain score to assess pain	Every 3 months up to 1 year post surgery
Secondary	Quality of life assessment	EORTC QLQ-C15 PAL	Every 3 months up to 1 year post surgery
Secondary	Quality of life assessment	Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0)	pre surgery and 1 month after surgery
Secondary	Quality of life assessment	EORTC QLQ-BM22	Every 3 months up to 1 year post surgery
Secondary	Treatment related toxicity	Using Common Terminology Criteria for Adverse Events	Every 3 months up to 1 year post surgery