An observational study in Spinal Metastases, Metastatic Epidural Spinal Cord Compression and Spinal Cord Compression, sponsored by Tianjin Medical University Cancer Institute and Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Observational
This study observes the effectiveness of high-precision radiation therapy using the Edge system after surgery for patients with spinal metastases. Spinal metastases can press on the spinal cord and cause pain, weakness, or paralysis. This treatment uses higher doses of radiation in fewer sessions (hypofractionated stereotactic body radiotherapy) delivered precisely by the Edge machine to target remaining tumor cells while protecting the spinal cord. The study aims to see if this approach improves local tumor control, improves neurological function, shortens treatment duration, and improves quality of life in these patients. The study is observational, meaning patients receive standard care, and data is collected to evaluate the outcomes.
This is a single-center, prospective, observational cohort study conducted at Tianjin Medical University Cancer Institute and Hospital to evaluate the clinical outcomes of postoperative Edge (RapidArc) Stereotactic Body Radiotherapy (SBRT) in patients with spinal metastases from solid tumors. A total of 50 patients with postoperative metastatic epidural spinal cord compression (MESCC) will be enrolled. The treatment protocol prescribes a total dose of 35 Gy in 5 fractions (7 Gy per fraction) delivered using the Edge system. The Edge system features sub-millimeter precision, six-dimensional dynamic positioning, and optical surface monitoring (OSMS), which allows for a steep dose gradient, high biological effective dose (BED), and maximal spinal cord protection. The study will evaluate local control rate (LC) and neurological improvement (Frankel score) at 3 months as the primary outcome. Secondary outcomes include 1-year and 2-year LC, neurological deterioration-free survival (NDFS), overall survival (OS), and quality of life (EORTC QLQ-C30). Adverse events including acute radiation myelitis and esophagitis will be monitored. Data will be analyzed using SPSS 27.0 and R 4.3.2, with survival curves generated via the Kaplan-Meier method and Cox regression models used for prognostic factor analysis.
52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 17 observational studies indexed under Spinal Cord Compression.
Browse Spinal Cord Compression studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 494 studies on the registry; 293 are open to participants now.
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Patients diagnosed with spinal metastases from solid tumors who underwent surgery and had residual metastatic epidural spinal cord compression (MESCC) requiring postoperative radiotherapy. All participants were enrolled at Tianjin Medical University Cancer Institute and Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received postoperative stereotactic body radiotherapy (SBRT) using the Edge system, prescribed as 35 Gy in 5 fractions (7 Gy per fraction).
Radiation: Stereotactic Body Radiotherapy
Postoperative stereotactic body radiotherapy using the Edge system, delivered as 35 Gy in 5 fractions (7 Gy per fraction).
Also known as: Edge System
Local Control Rate (LC)
Proportion of patients with local tumor control, assessed by MRI showing residual tumor volume changes at 3 months post-treatment.
Time frame: 3 months post-treatment
Neurological Deterioration-Free Survival (NDFS)
Time from treatment initiation to neurological deterioration or death.
Time frame: 1 year and 2 years
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Time frame: 1 year and 2 years
Quality of Life (QoL)
Change in quality of life scores assessed by the EORTC QLQ-C30 questionnaire.
Time frame: Baseline, 3 months, 1 year, and 2 years post-treatment
Incidence of Adverse Events
Incidence of acute radiation myelitis, esophagitis, vertebral fractures, and skin reactions, graded according to CTCAE v5.0.
Time frame: Up to 2 years post-treatment
Plan to share: No — Individual participant data (IPD) will not be shared to protect patient confidentiality and adhere to institutional data protection policies.
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Tianjin Medical University Cancer Institute and Hospital →