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Post Operative RT for Limited Spine Metastases

ConditionSpine Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital

About this trial

To evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by SBRT or conventional RT. The study primary endpoint is one year local control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.

Patients with maximum two continuous level of spine metastases need for surgery are eligible. Patients who have other spine metastases but not necessary for surgery are allowed.

A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.

Patients aged at least 20 years old are eligible.

Disqualifiers

Patients received prior radiotherapy to the index spine level.

Patients who cannot receive Gadolinium enhanced MRI due to pacemaker or metal implant or who cannot receive contrast enhanced CT scan due to impaired renal function.

Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.

Patients who cannot tolerate radiotherapy immobilization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spondylectomy

    Procedure/Surgery

    Patient will be randomized to treated by spondylectomy or debulking surgery. Spondylectomy implied total resection of involved spine; while debulking surgery means partial resection of involved spine.

  • SBRT

    Radiation

    Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.

Treatment groups

111 Participants
are divided into 3 treatment groups
Group A: Spondylectomy with Conventional RTExperimental treatment 1 intervention
Group B: Debulking surgery with Conventional RTActive comparator 2 interventions
Group C: Debulking surgery with SBRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Local control

Number of patients with locally controlled disease of index spine after intervention

Time frame
12 months post surgery

Secondary outcomes

1

Overall survival

Survival from treatment to death

Time frame
12 months post surgery
2

pain control

using numerical pain score to assess pain

Time frame
Every 3 months up to 1 year post surgery
3

Quality of life assessment

EORTC QLQ-C15 PAL

Time frame
Every 3 months up to 1 year post surgery
4

Quality of life assessment

Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0)

Time frame
pre surgery and 1 month after surgery

Other outcomes

Sponsors and contacts

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

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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