Post Operative RT for Limited Spine Metastases

Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Spine Metastases
• Intervention / Treatment: Procedure: Spondylectomy; Radiation: SBRT

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wen Chi Yang; Phone Number: +886223123456; Email: claireds23@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Wen Chi Yang; Phone Number: +886223123456; Email: claireds23@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.
2. 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.
3. A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.
4. Patients aged at least 20 years old are eligible.
5. Life expectancy of ≥ 6 months.
6. ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment)
7. No prior RT to the index spine level(s)
8. Women of childbearing potential must practice adequate contraception
9. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.

Exclusion Criteria:

1. Patients received prior radiotherapy to the index spine level.
2. 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.
3. Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
4. Patients who cannot tolerate radiotherapy immobilization.

5. Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:

   1. Uncontrolled active infection requiring intravenous antibiotics at the time of registration
   2. Transmural myocardial infarction ≤ 6 months prior to registration.
   3. Life-threatening uncontrolled clinically significant cardiac arrhythmias.
   4. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
   5. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
   6. Uncontrolled psychiatric disorder.
6. Pregnant or breast-feeding women

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spondylectomy with Conventional RT; Spondylectomy for involved spine level followed by conventional RT 20Gy in 5 fractions	Procedure: Spondylectomy; 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.
Active Comparator: Debulking surgery with Conventional RT; Debulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions	Procedure: Spondylectomy; 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.; Radiation: SBRT; Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.
Experimental: Debulking surgery with SBRT; Debulking surgery for involved spine level followed by SBRT 24Gy in 12 fractions	Radiation: SBRT; Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control	Number of patients with locally controlled disease of index spine after intervention	12 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Survival from treatment to death	12 months post surgery
pain control	using numerical pain score to assess pain	Every 3 months up to 1 year post surgery
Quality of life assessment	EORTC QLQ-C15 PAL	Every 3 months up to 1 year post surgery
Quality of life assessment	Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0)	pre surgery and 1 month after surgery
Quality of life assessment	EORTC QLQ-BM22	Every 3 months up to 1 year post surgery
Treatment related toxicity	Using Common Terminology Criteria for Adverse Events	Every 3 months up to 1 year post surgery

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stereotactic body radiotherapy; Spondylectomy; Separation surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 202204039RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD sharing required by other researchers will be discussed in institution

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No