En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.

Recruiting now

Conditions studied: Spinal Metastases, Spinal Tumor, Radiotherapy, Malignant Bone Tumor, Surgery

In brief

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

Key facts

Study ID: NCT06120426
Run by: Shanghai Changzheng Hospital
People needed: 182
Starts: 2023-07-01
Expected to finish: 2027-07-01
Last updated by the study team: 2023-11-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Shanghai Changzheng hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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