The Effect of Radiotherapy After Separation Surgery for Spinal Metastases

NCT07527884 | Not Yet Recruiting

• 1 other identifier: 2025SL080
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spinal Metastases; Spinal Tumor; Radiotherapy; Separation Surgery

Keywords

spinal metastases; spinal tumor; radiotherapy; separation surgery

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Time from the date of surgery to the first documented disease progression or death from any cause, whichever occurs first.

  Baseline up to 24 months.

Secondary Outcomes (4)

• Overall Survival（OS）

  Baseline up to 24 months.

• Pain Assessment

  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

  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

  Baseline up to 24 months.

Study Arms (2)

No Radiotherapy Arm

NO INTERVENTION

The patients with this arm do not receive radiotherapy after the separation surgery.

Postoperative Radiotherapy Arm.

EXPERIMENTAL

Patients with spinal metastasis undergo radiotherapy after the separation surgery.

Radiation: radiotherapy

Interventions

radiotherapy RADIATION

The patients receive radiotherapy after the separation surgery.

Postoperative Radiotherapy Arm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Related Publications (9)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 RESULT

MeSH Terms

Conditions

Spinal Cord Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Wei Xu

CONTACT

+8613761278657; xuwei_spine@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04