NCT06120426 En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
| NCT ID | NCT06120426 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Changzheng Hospital |
| Condition | Spinal Metastases |
| Study Type | OBSERVATIONAL |
| Enrollment | 182 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 182 participants in total. It began in 2023-07-01 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06120426 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Spinal Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06120426 currently recruiting?
Yes, NCT06120426 is actively recruiting participants. Contact the research team at jianruxiao83@163.com for enrollment information.
Where is the NCT06120426 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06120426 clinical trial?
NCT06120426 is sponsored by Shanghai Changzheng Hospital. The trial plans to enroll 182 participants.