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Intraoperative Radiotherapy in Treating Spinal Metastases

ConditionSpinal Metastases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorShanghai Changzheng Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraoperative radiotherapy (IORT)

    Radiation

    Intraoperative radiotherapy (IORT, 15-20 Gy, 20-50min)

  • Stereotactic body radiotherapy (SBRT)

    Radiation

    postoperative stereotactic body radiotherapy (SBRT, 30Gy, 5 fractions, 3 weeks)

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Decompression surgery + IORTExperimental treatment 1 intervention
Group B: Decompression surgery + postoperative SBRTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Local control rate

The local control of tumor in the surgical field

Time frame
2 years

Secondary outcomes

1

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.

Time frame
2 years
2

Progression-free survival

The survival time between the day after treatments and the date of any evidence proving tumor progression or final follow-up

Time frame
2 years
3

Overall survival

The survival time between the day after treatments and the date of all-cause death or final follow-up

Time frame
2 years
4

Radiation-related complications

The complications assciated with the radiation process

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Changzheng Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: