Recruiting NCT05495399
Post Operative RT for Limited Spine Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spondylectomy, SBRT.
- Who it may be relevant to
- Registry conditions: Spine Metastases. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy
Overview
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.
Interventions
- 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.
Primary outcome measures
- Local control [Time frame: 12 months post surgery]
Secondary outcome measures (6)
- Overall survival [Time frame: 12 months post surgery]
- pain control [Time frame: Every 3 months up to 1 year post surgery]
- Quality of life assessment [Time frame: Every 3 months up to 1 year post surgery]
- Quality of life assessment [Time frame: pre surgery and 1 month after surgery]
- Quality of life assessment [Time frame: Every 3 months up to 1 year post surgery]
- Treatment related toxicity [Time frame: Every 3 months up to 1 year post surgery]
Eligibility criteria
Inclusion 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.
Exclusion criteria
- 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 of the protocol, or limit compliance with study requirements, defined as follows:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT05495399 · 202204039RINA