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New treatment option for Spine Metastases
Official title Post Operative RT for Limited Spine Metastases
ClinicalTrials.gov ID: NCT05495399
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or...
- Patients with maximum two continuous level of spine metastases need for surgery are eligible. Patients who have other spine metastases but not...
- A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.
- Patients aged at least 20 years old are eligible.
- Life expectancy of ≥ 6 months.
You likely can't join if
- Patients received prior radiotherapy to the index spine level.
- Patients who cannot receive Gadolinium enhanced MRI due to pacemaker or metal implant or who cannot receive contrast enhanced CT scan due to impaired...
- Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
- Patients who cannot tolerate radiotherapy immobilization.
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere...
- Uncontrolled active infection requiring intravenous antibiotics at the time of registration
See the full eligibility criteria
- Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.
- 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.
- A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.
- Patients aged at least 20 years old are eligible.
- Life expectancy of ≥ 6 months.
- ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment)
- No prior RT to the index spine level(s)
- Women of childbearing potential must practice adequate contraception
- Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.
- Patients received prior radiotherapy to the index spine level.
- 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.
- Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
- Patients who cannot tolerate radiotherapy immobilization.
- 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...
- Uncontrolled active infection requiring intravenous antibiotics at the time of registration
- Transmural myocardial infarction ≤ 6 months prior to registration.
- Life-threatening uncontrolled clinically significant cardiac arrhythmias.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
- Uncontrolled psychiatric disorder.
- Pregnant or breast-feeding women
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.