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Trial Title: Post Operative RT for Limited Spine Metastases

NCT ID: NCT05495399

Condition: Spine Metastases

Conditions: Official terms:
Neoplasm Metastasis

Conditions: Keywords:
Stereotactic body radiotherapy
Spondylectomy
Separation surgery

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Spondylectomy
Description: 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.
Arm group label: Debulking surgery with Conventional RT
Arm group label: Spondylectomy with Conventional RT

Intervention type: Radiation
Intervention name: SBRT
Description: Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.
Arm group label: Debulking surgery with Conventional RT
Arm group label: Debulking surgery with SBRT

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.

Criteria for 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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Zip: 100
Country: Taiwan

Status: Recruiting

Contact:
Last name: Wen Chi Yang

Phone: +886223123456
Email: claireds23@ntuh.gov.tw

Start date: August 1, 2022

Completion date: July 2027

Lead sponsor:
Agency: National Taiwan University Hospital
Agency class: Other

Source: National Taiwan University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05495399

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