Comparing two surgical approaches for spinal oligometastatic tumors with radiotherapy
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor-A Multi-center, Prospective, Randomized, Controlled Study.
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 |
|---|---|
| Enrollment | 182 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06120426 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with oligometastatic spinal cancer and specific imaging criteria indicating limited metastatic spread.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai Changzheng hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jianru Xiao, Doctor
- Email: jianruxiao83@163.com
- Phone: +86 13701785283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.