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Trial Title:
Intraoperative Radiotherapy in Treating Spinal Metastases
NCT ID:
NCT06093854
Condition:
Spinal Metastases
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
spinal metastases
intraoperative radiotherapy
stereotactic body radiotherapy
decompression surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
1. Decompression surgery + IORT (15-20 Gy, 20-50min）
2. Decomression surgery + postoperative SBRT ( 30Gy, 5 fractions, 3 weeks)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Intraoperative radiotherapy (IORT)
Description:
Intraoperative radiotherapy (IORT, 15-20 Gy, 20-50min)
Arm group label:
Decompression surgery + IORT
Intervention type:
Radiation
Intervention name:
Stereotactic body radiotherapy (SBRT)
Description:
postoperative stereotactic body radiotherapy (SBRT, 30Gy, 5 fractions, 3 weeks)
Arm group label:
Decompression surgery + postoperative SBRT
Summary:
In order to provide theoretical evidence for the comprehensive and standardized treatment
of spinal metastases with pathological fractures and/or spinal cord compression, the
investigators conduct this trial to investigate the efficacy and safety of IORT and
postoperative SBRT in adjuvant treatment of metastatic spinal tumors after posterior
decompression surgery by recruiting patients with spinal metastases who met the inclusion
criteria, and randomly divided them into the following treatment cohorts: 1)
decompression surgery + IORT (15-20 Gy, 20-50min）; 2) decompression surgery and
postoperative SBRT(30Gy, 5 fractions, 3 weeks).
Detailed description:
Spine is the most common metastatic site for advanced malignancies, accounting for about
70% of all patients with bone metastasis. Approximately 40% -70% of patients with
advanced cancer eventually develop spinal metastases.
Spinal metastases require multidisciplinary treatments, and surgical decompression
surgery is the preferred treatment in managing spinal metastases with bone related
events, especially those with spinal cord compression. The purpose of decompression
surgery is to directly relieve nerve compression, alleviate pain, rebuild spinal
stability, and reduce tumor burden, which improves the quality of life, and extend the
life span indirectly.
At the same time, radiotherapy is also an indispensable treatment for spinal metastases
after surgical decompression. The purpose of radiotherapy is to remove residual tumor
lesions, alleviate pain, and prevent further pathological fractures. Recent years have
witnessed the rapid development of stereotactic bone radiotherapy (SBRT). As reported,
SBRT can not only increase the radiation dose at the tumor site, but also reduce
radiation damage to the spinal cord and surrounding normal tissues, which is the
preferred adjuvant treatment for patients with metastatic spinal tumors. However, SBRT
has the several risks, including radiation myelitis, delayed vertebral pathological
fractures, local skin allergies, radiotherapy side effects in the esophagus and lungs,
and duodenal perforation. Moreover, stereotactic radiotherapy technology has higher costs
compared to traditional external beam radiotherapy.
Recently, the application of intraoperative radiotherapy (IORT) can effectively reduce
the direct radiation for surrounding normal tissues and maximally eliminate the residual
tumor cells. The advantages of IORT include: ① immediate reduction of the possibility of
tumor cell expansion after surgery; ② Safe direct radiation and effective protection of
normal tissues beyond the radiation depth; ③ To effectively protect adjacent normal
tissues, light-limiting tubes with different diameters can be selected based on the size
and range of tumor; ④ Shortening treatment course with lower costs and better compliance;
⑤ Slight systemic side effects and bone marrow suppression.
To the knowledge, no research focuses on the efficacy of IORT and SBRT in the adjuvant
treatment of spinal metastases. Therefore, in order to provide theoretical evidence for
the comprehensive and standardized treatment of spinal metastases with pathological
fractures and/or spinal cord compression, the investigators conduct this trial to
investigate the efficacy and safety of IORT and postoperative SBRT in adjuvant treatment
of metastatic spinal tumors after posterior decompression surgery by recruiting patients
with spinal metastases who met the inclusion criteria, and randomly divided them into the
following treatment cohorts: 1) decompression surgery + IORT (15-20 Gy, 20-50min）; 2)
decompression surgery and postoperative SBRT(30Gy, 5 fractions, 3 weeks).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Clinical diagnosis of spinal metastases;
- Estimated survival time more than 3 months;
- The spinal instability neoplastic score (SINS) >12;
- The general condition allows to recieve surgery;
- Single or multiple metastatic lesions with only one site presenting epidural spinal
cord compression;
- signed informed consent.
Exclusion Criteria:
- Clinical diagnosis of primary spinal tumors;
- Presence of metastases in central nerve system;
- Isolated lesion undergoing en bloc resection;
- Mental disorder and/or intellectual dificiency;
- Refusing to accept follow-up;
- without signing informed consent.
Gender:
All
Minimum age:
35 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Changzheng Hospital
Address:
City:
Shanghai
Zip:
200003
Country:
China
Start date:
January 2024
Completion date:
January 2027
Lead sponsor:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Source:
Shanghai Changzheng Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06093854
