The Effect of Radiotherapy After Separation Surgery for Spinal Metastases

April 9, 2026 updated by: Shanghai Changzheng Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Radiotherapy Arm
The patients with this arm do not receive radiotherapy after the separation surgery.
Experimental: Postoperative Radiotherapy Arm.
Patients with spinal metastasis undergo radiotherapy after the separation surgery.
Radiation: radiotherapy
The patients receive radiotherapy after the separation surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Baseline up to 24 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival（OS）
Time Frame: Baseline up to 24 months.
From the date of surgery until the date of death from any cause.
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.
Visual Analogue Scale (VAS)
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.
EORTC QLQ-C30 V3.0 Scale
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.
All related complications after the surgery.
Baseline up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

August 19, 2025

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025SL080

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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