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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