Clinical trial · Interventional
The Effect of Radiotherapy After Separation Surgery for Spinal Metastases
Postoperative Radiotherapy Versus No Radiotherapy Following Separation Surgery for Spinal Metastases: A Mixed Cohort Study
NCT07527884CI-TRIAL-00108077recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiotherapy | — | UNRESOLVED | — |
| Separation Surgery | — | UNRESOLVED | — |
| Spinal Metastases | — | UNRESOLVED | — |
| Spinal Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- No Radiotherapy Arm
- description
- The patients with this arm do not receive radiotherapy after the separation surgery.
- type
- EXPERIMENTAL
- label
- Postoperative Radiotherapy Arm.
- description
- Patients with spinal metastasis undergo radiotherapy after the separation surgery.
- interventionNames
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Baseline up to 24 months.
- description
- Time from the date of surgery to the first documented disease progression or death from any cause, whichever occurs first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age over 18 years old, gender not limited; 2. The patient has undergone separation surgery within 3 weeks; 3. 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; 4. The expected survival period is ≥ 6 months; 5. The patient has signed the informed consent form. Exclusion Criteria: 1. Patients with poor general condition and those who are intolerant to radiotherapy, chemotherapy, and targeted therapy; 2. Patients whose treatment segments have not received any other surgical treatment or radiotherapy; 3. Patients who participated in other clinical trials of drugs or medical devices within 3 months before enrollment; 4. Other situations judged by the investigator as making the subject unsuitable for enrollment.
References
Publications (9)
- RESULTReck 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
- RESULTDugan 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
- RESULTGoetz 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
- RESULTKumar 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
- RESULTChang 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
- RESULTLaufer 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.