The Effect of Radiotherapy After Separation Surgery for Spinal Metastases

Official title

Postoperative Radiotherapy Versus No Radiotherapy Following Separation Surgery for Spinal Metastases: A Mixed Cohort Study

Overview

The aim of this clinical study is to explore the impact of whether radiotherapy is administered after spinal metastasis surgery on the prognosis and survival of patients, to describe the clinical outcomes, and to optimize future clinical decisions.

Detailed description

Based on the GLOBOCAN 2020 report, there were approximately 19.3 million new cancer cases and 10 million cancer-related deaths worldwide in 2020. The spine is one of the most common sites for metastatic malignancies, with approximately 30%-70% of patients with malignant tumors developing spinal metastases. Malignant spinal metastases can lead to symptoms such as pain, hypercalcemia, spinal instability, vertebral pathological fractures, and compression of the spinal cord and nerve roots. If the symptoms of bone metastases are not effectively controlled, they can cause psychological problems such as pain, anxiety, depression, despair, and loneliness, severely impacting the quality of life and accelerating the process of death.

The primary treatment goal for patients with spinal metastatic cancer is palliative care, which includes the preservation of neurological function, local tumor control, restoration of spinal stability, and alleviation of associated symptoms to improve the quality of life of patients. Separation surgery followed by postoperative radiotherapy is currently one of the most common treatment regimens for spinal metastatic cancer patients. Although postoperative radiotherapy can provide some degree of local control over spinal metastases, radiotherapy is associated with potential risks, such as radiation-induced myelitis, vertebral compression fractures, local control failure, and surgical wound infections. Moreover, radiotherapy is ineffective in 20-30% of patients. Furthermore, the maximum cumulative radiation dose tolerable by the spinal cord is 45-50Gy, beyond which the spine can no longer receive radiotherapy. In recent years, significant breakthroughs in systemic therapies such as targeted therapy and immunotherapy have dramatically improved local control and survival rates for various spinal metastatic cancers (such as lung, breast, and prostate cancer); in some cases, systemic therapy alone can effectively control spinal metastases.

The Spine Tumor Center at Shanghai Changzheng Hospital is continuously dedicated to exploring and researching new treatment methods for spinal metastatic cancer. In this clinical trial, we aim to compare data from spinal metastatic cancer patients with indications for separation surgery who undergo systemic therapy alone following separation surgery with those who undergo radiotherapy after separation surgery at the same center. Through a rigorous prospective cohort study, we hope to provide new and effective treatment strategies for the control of local lesions and improvement in the quality of life for spinal metastatic cancer patients.

Interventions

• Radiation radiotherapy
  The patients receive radiotherapy after the separation surgery.

Primary outcome measures

• Progression-Free Survival (PFS) [Time frame: Baseline up to 24 months.]

Secondary outcome measures (4)

• Overall Survival（OS） [Time frame: Baseline up to 24 months.]
• Pain Assessment [Time frame: One day before the operation, within 2 weeks after the operation, 3 months after the operation, 6 months after the operation, 12 months after the operation, 18 months after the operation, and 24 months after the operation.]
• Quality of Life Evaluation [Time frame: One day before the operation, within 2 weeks after the operation, 3 months after the operation, 6 months after the operation, 12 months after the operation, 18 months after the operation, and 24 months after the operation.]
• Complications [Time frame: Baseline up to 24 months.]

Eligibility criteria

Inclusion criteria

• Age over 18 years old, gender not limited;
• The patient has undergone separation surgery within 3 weeks;
• The pathological result of the separation surgery site of the patient indicates that the lesion is a metastatic tumor, and the primary lesion is located outside the spine;
• The expected survival period is ≥ 6 months;
• The patient has signed the informed consent form.

Exclusion criteria

• Patients with poor general condition and those who are intolerant to radiotherapy, chemotherapy, and targeted therapy;
• Patients whose treatment segments have not received any other surgical treatment or radiotherapy;
• Patients who participated in other clinical trials of drugs or medical devices within 3 months before enrollment;
• Other situations judged by the investigator as making the subject unsuitable for enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8. PMID 27718847
• Dugan JE, Long CC, Chanbour H, Bendfeldt GA, Suryateja Gangavarapu L, Younus I, Jonzzon S, Ahmed M, Luo LY, Berkman RA, Lugo-Pico JG, Abtahi AM, Stephens BF, Zuckerman SL. Obstacles to receiving postoperative radiation therapy following separation surgery for metastatic spine disease. J Neurosurg Spine. 2024 Jun 28;41(3):416-427. doi: 10.3171/2024.4.SPINE231254. Print 2024 Sep 1. PMID 38941648
• Goetz MP, Callstrom MR, Charboneau JW, Farrell MA, Maus TP, Welch TJ, Wong GY, Sloan JA, Novotny PJ, Petersen IA, Beres RA, Regge D, Capanna R, Saker MB, Gronemeyer DH, Gevargez A, Ahrar K, Choti MA, de Baere TJ, Rubin J. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004 Jan 15;22(2):300-6. doi: 10.1200/JCO.2004.03.097. PMID 14722039
• Kumar N, Madhu S, Bohra H, Pandita N, Wang SSY, Lopez KG, Tan JH, Vellayappan BA. Is there an optimal timing between radiotherapy and surgery to reduce wound complications in metastatic spine disease? A systematic review. Eur Spine J. 2020 Dec;29(12):3080-3115. doi: 10.1007/s00586-020-06478-5. Epub 2020 Jun 15. PMID 32556627
• Chang JH, Shin JH, Yamada YJ, Mesfin A, Fehlings MG, Rhines LD, Sahgal A. Stereotactic Body Radiotherapy for Spinal Metastases: What are the Risks and How Do We Minimize Them? Spine (Phila Pa 1976). 2016 Oct 15;41 Suppl 20(Suppl 20):S238-S245. doi: 10.1097/BRS.0000000000001823. PMID 27488294
• 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. PMID 23709750
• 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: 10.1016/j.spinee.2017.10.070. Epub 2017 Nov 6. PMID 29122701
• 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. PMID 28640703

Identifiers

NCT: NCT07527884 · 2025SL080

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗