Comparing two surgical approaches for spinal oligometastatic tumors with radiotherapy
Official title: En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor-A Multi-center, Prospective, Randomized, Controlled Study.
Run by Shanghai Changzheng Hospital · NCT06120426 · Data updated 2026-11-12
This study is testing whether two different types of surgery combined with radiation can help people with spinal cancer live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 182 (estimated) |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | July 1, 2023 |
| Main results expected | July 1, 2025 |
| Study ends | July 1, 2027 |
| Registry record updated | November 13, 2023 |
| Trial ID | NCT06120426 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with oligometastatic spinal cancer and specific imaging criteria indicating limited metastatic spread.
✕Probably not a fit
Patients with primary spinal tumors or those with extensive metastatic disease involving more than three organs or five lesions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of En bloc surgery versus separation surgery combined with radiotherapy on the survival and prognosis of patients with spinal oligometastatic cancer. It aims to determine the clinical outcomes of these treatment approaches and optimize future treatment strategies. Patients with oligometastatic disease, characterized by limited metastatic spread, may benefit from more aggressive local treatments, including surgery and targeted radiotherapy. The study will analyze the impact of these interventions on patient survival and quality of life.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and treatment outcomes for patients with spinal oligometastatic tumors.
How similar studies have gone: While there is ongoing research in the field of oligometastatic disease, this specific comparison of surgical approaches combined with radiotherapy is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) Be able to sign written informed consent. * 2\) Age range from 18 to 75 years old, regardless of gender. * 3\) Within conservative treatment, the patient still has uncontrollable pain, metastatic cancer lesions that still progress, spinal instability/potential instability, or symptoms of spinal cord/nerve compression. * 4\) After the patient underwent Positron Emission Tomography-Computed Tomography (PET-CT) examination, it was indicated that there were no more than 3 metastatic organs and no more than 5 metastatic lesions in the whole body of cancer. Among them, there was at least 1 spinal metastasis and at most 5 spinal metastases. * 5\) Imaging examinations (enhanced MRI, enhanced CT, X-ray) indicate the presence of spinal metastasis. * 6\) The expected survival period is ≥ 6 months. * 7)No other surgical contraindications Exclusion Criteria: * 1\) Primary tumors of the spine or multiple tumors of the body, with\>3 metastatic organs and\>5 metastatic sites. * 2\) Previously underwent spinal surgery, or received radiotherapy for the responsible segment of this treatment. * 3\) Severe heart, lung, liver, kidney or other diseases affecting the surgery. * 4\) Having cognitive impairment, sensory aphasia, and inability to understand basic instructions. * 5\) Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment. * 6\) Infectious diseases. * 7\) Refuse to follow up or participate. * 8\) The researchers determine that the patients are not suitable for enrollment this clinical trail.
Where it's running
-
Shanghai Changzheng hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Jianru Xiao, Doctor
- Email: jianruxiao83@163.com
- Phone: +86 13701785283
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Radiotherapy after Separation Surgery for Spinal Metastases
This study tests whether giving radiotherapy after separation surgery helps people with spinal metastases live longer and feel better.
-
Analysis of outcomes and side effects in patients receiving radiation therapy
This study looks at the results and side effects of radiation therapy in patients at Winterthur Cantonal Hospital to see how treatment can be improved for future patients.
-
Primary tumor removal with targeted lymph node removal plus radiation for biliary tract cancer with lymph node spread
This phase II study tests whether removing the main tumor and select nearby lymph nodes, followed by postoperative radiation, helps patients with biliary tract cancer and lymph node metastases.
-
Stereotactic body radiation therapy for spinal metastases with epidural compression
This study tests whether SBRT can safely help adults with spinal metastases that compress the spinal cord see if the treatment works in reducing issues from their cancer.
-
Tributyrin as a dietary supplement to help prevent radiation-induced rectal injury during rectal cancer chemoradiation
This study tests whether adding tributyrin to standard chemoradiotherapy helps prevent acute radiation-induced rectal injury in people with locally advanced rectal cancer.
-
Postoperative Edge SBRT for Spinal Metastases
This observational study tests whether high-precision postoperative SBRT with the Edge system can improve local control and neurological outcomes in patients with spinal metastases after surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.