Intraoperative Radiotherapy in Treating Spinal Metastases

Spinal Metastases Clinical Trial

Official title:

The Efficacy and Safety of Intraoperative Radiotherapy Vesus Stereotactic Body Radiotherapy in Managing Spinal Metastases: A Prospective, Single-center, Open-label, Non-inferior, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06093854
• Other study ID #: 2022SL052
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2027

Study information

• Verified date: October 2023
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

Intervention

Radiation:
• Intraoperative radiotherapy (IORT)
Intraoperative radiotherapy (IORT, 15-20 Gy, 20-50min)
• Stereotactic body radiotherapy (SBRT)
postoperative stereotactic body radiotherapy (SBRT, 30Gy, 5 fractions, 3 weeks)

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

References & Publications (14)

Barzilai O, Laufer I, Yamada Y, Higginson DS, Schmitt AM, Lis E, Bilsky MH. Integrating Evidence-Based Medicine for Treatment of Spinal Metastases Into a Decision Framework: Neurologic, Oncologic, Mechanicals Stability, and Systemic Disease. J Clin Oncol. 2017 Jul 20;35(21):2419-2427. doi: 10.1200/JCO.2017.72.7362. Epub 2017 Jun 22. — View Citation

Barzilai O, McLaughlin L, Amato MK, Reiner AS, Ogilvie SQ, Lis E, Yamada Y, Bilsky MH, Laufer I. Predictors of quality of life improvement after surgery for metastatic tumors of the spine: prospective cohort study. Spine J. 2018 Jul;18(7):1109-1115. doi: — View Citation

Bludau F, Welzel G, Reis T, Schneider F, Sperk E, Neumaier C, Ehmann M, Clausen S, Obertacke U, Wenz F, Giordano FA. Phase I/II trial of combined kyphoplasty and intraoperative radiotherapy in spinal metastases. Spine J. 2018 May;18(5):776-781. doi: 10.10 — View Citation

Calvo FA. Intraoperative irradiation: precision medicine for quality cancer control promotion. Radiat Oncol. 2017 Feb 2;12(1):36. doi: 10.1186/s13014-017-0764-5. — View Citation

Correia D, Moullet B, Cullmann J, Heiss R, Ermis E, Aebersold DM, Hemmatazad H. Response assessment after stereotactic body radiation therapy for spine and non-spine bone metastases: results from a single institutional study. Radiat Oncol. 2022 Feb 21;17( — View Citation

Laufer I, Rubin DG, Lis E, Cox BW, Stubblefield MD, Yamada Y, Bilsky MH. The NOMS framework: approach to the treatment of spinal metastatic tumors. Oncologist. 2013 Jun;18(6):744-51. doi: 10.1634/theoncologist.2012-0293. Epub 2013 May 24. — View Citation

Myrehaug S, Sahgal A, Hayashi M, Levivier M, Ma L, Martinez R, Paddick I, Regis J, Ryu S, Slotman B, De Salles A. Reirradiation spine stereotactic body radiation therapy for spinal metastases: systematic review. J Neurosurg Spine. 2017 Oct;27(4):428-435. — View Citation

Orecchia R, Veronesi U, Maisonneuve P, Galimberti VE, Lazzari R, Veronesi P, Jereczek-Fossa BA, Cattani F, Sangalli C, Luini A, Caldarella P, Venturino M, Sances D, Zurrida S, Viale G, Leonardi MC, Intra M. Intraoperative irradiation for early breast canc — View Citation

Patchell RA, Tibbs PA, Regine WF, Payne R, Saris S, Kryscio RJ, Mohiuddin M, Young B. Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial. Lancet. 2005 Aug 20-26;366(9486):643 — View Citation

Sahgal A, Myrehaug SD, Siva S, Masucci GL, Maralani PJ, Brundage M, Butler J, Chow E, Fehlings MG, Foote M, Gabos Z, Greenspoon J, Kerba M, Lee Y, Liu M, Liu SK, Thibault I, Wong RK, Hum M, Ding K, Parulekar WR; trial investigators. Stereotactic body radi — View Citation

Thibault I, Chang EL, Sheehan J, Ahluwalia MS, Guckenberger M, Sohn MJ, Ryu S, Foote M, Lo SS, Muacevic A, Soltys SG, Chao S, Gerszten P, Lis E, Yu E, Bilsky M, Fisher C, Schiff D, Fehlings MG, Ma L, Chang S, Chow E, Parelukar WR, Vogelbaum MA, Sahgal A. — View Citation

Vaidya JS, Bulsara M, Baum M, Alvarado M, Bernstein M, Massarut S, Saunders C, Sperk E, Wenz F, Tobias JS; TARGIT-A investigators. Intraoperative radiotherapy for breast cancer: powerful evidence to change practice. Nat Rev Clin Oncol. 2021 Mar;18(3):187-188. doi: 10.1038/s41571-021-00471-7. No abstract available. — View Citation

Vaidya JS, Bulsara M, Saunders C, Flyger H, Tobias JS, Corica T, Massarut S, Wenz F, Pigorsch S, Alvarado M, Douek M, Eiermann W, Brew-Graves C, Williams N, Potyka I, Roberts N, Bernstein M, Brown D, Sperk E, Laws S, Sutterlin M, Lundgren S, Holmes D, Vin — View Citation

Wenz F, Schneider F, Neumaier C, Kraus-Tiefenbacher U, Reis T, Schmidt R, Obertacke U. Kypho-IORT--a novel approach of intraoperative radiotherapy during kyphoplasty for vertebral metastases. Radiat Oncol. 2010 Feb 11;5:11. doi: 10.1186/1748-717X-5-11. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate	The local control of tumor in the surgical field	2 years
Secondary	Health-related quality of life	The "Functional Assessment of Cancer Therapy -General" (FACT-G) Scale (Minimum: 0; Maximum: 108 ) is utilized to evaluate the health-related quality of life after treatments, and higher scores mean a worse outcome.	2 years
Secondary	Progression-free survival	The survival time between the day after treatments and the date of any evidence proving tumor progression or final follow-up	2 years
Secondary	Overall survival	The survival time between the day after treatments and the date of all-cause death or final follow-up	2 years
Secondary	Radiation-related complications	The complications assciated with the radiation process	2 years