Clinical trial NCT06120426: En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Metastases
Spinal Tumor
Radiotherapy
Malignant Bone Tumor
Surgery
Keywords: Total enbloc spondylectomy
Oligometastases
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Peking University People's Hospital
name: Henan Cancer Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Sun Yat-sen University
name: Zhejiang University
name: Tianjin Hospital
name: The First Affiliated Hospital of Nanchang University
name: The Third Affiliated Hospital of Southern Medical University
First posted: 2023-11-07
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: According to the literature results, the median survival period of the experimental group was 20 months, while the median survival period of the control group was 11 months. The total study duration (enrollment+follow-up) was 48 months, and the enrollment time (assuming uniform enrollment speed) was 24 months. The bilateral alpha was 0.05, the beta was 0.2, and the ratio of sample size between the two groups was 2 (experimental group: control group). Through the difference test of median survival time, the experimental sample size was calculated: 110 cases in the experimental group, 55 cases in the control group, a total of 165 cases, Considering 10% detachment, a total of 182 samples are required.

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

Detailed description: Patients with oligometastatic diseases have been shown to have better prognosis than those with multiple metastatic diseases, and some patients have achieved long-term survival, thus being considered to benefit from more aggressive treatment. Active local treatment, including surgery and/or targeted radiotherapy, such as Stereotactic Radiosurgery (SRS) and Stereotactic body radiotherapy (SBRT), can be performed before or after systemic treatment. For both primary and oligometastatic tumors, radical treatment should be considered in order to achieve better survival and prognosis. The current research has explored the different effects of oligometastatic disease status on the prognosis of various cancers. However, there is currently no clear clinical or experimental confirmation of the impact on the survival and treatment outcomes of patients with oligometastatic spinal cancer. The purpose of this clinical trial is to explore the impact of En bloc hand surgery and separation surgery combined with radiotherapy on the prognosis and survival of patients with oligometastatic spinal cancer, Describe clinical outcomes 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.

Primary outcomes:
measure: Overall Survival(OS)
timeFrame: after surgery until death due to primary disease or responsible segment
Secondary outcomes:
measure: Local Control Rate(LRC)
timeFrame: a 20% increase in the total diameter of the target lesion observed on imaging from the beginning of the patient's current treatment to baseline.
measure: Progression-Free Survival(PFS)
timeFrame: The period between the patient receiving this treatment and observing local progression or death from any cause.
measure: Brief Pain inventory
timeFrame: 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery.
measure: EORTC Quality of Life Questionnaire - Core 30
timeFrame: 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery
measure: Complication
timeFrame: 1 month, 3 months, 6 months, and 12 months after surgery.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng hospital
state: Shanghai
Study officials:
References:
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