Post Operative RT for Limited Spine Metastases

NCT05495399 | Recruiting

• 1 other identifier: 202204039RINA
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spine Metastases

Keywords

Stereotactic body radiotherapy; Spondylectomy; Separation surgery

Outcome Measures

Primary Outcomes (1)

• Local control

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

  12 months post surgery

Secondary Outcomes (6)

• Overall survival

  12 months post surgery

• pain control

  Every 3 months up to 1 year post surgery

• Quality of life assessment

  Every 3 months up to 1 year post surgery

• Quality of life assessment

  pre surgery and 1 month after surgery

• Quality of life assessment

  Every 3 months up to 1 year post surgery

Study Arms (3)

Spondylectomy with Conventional RT

EXPERIMENTAL

Spondylectomy for involved spine level followed by conventional RT 20Gy in 5 fractions

Procedure: Spondylectomy

Debulking surgery with Conventional RT

ACTIVE COMPARATOR

Debulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions

Procedure: Spondylectomy; Radiation: SBRT

Debulking surgery with SBRT

EXPERIMENTAL

Debulking surgery for involved spine level followed by SBRT 24Gy in 12 fractions

Radiation: SBRT

Interventions

Spondylectomy PROCEDURE

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.

Debulking surgery with Conventional RT; Spondylectomy with Conventional RT

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.

Debulking surgery with Conventional RT; Debulking surgery with SBRT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Life expectancy of ≥ 6 months.
• ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment)
• No prior RT to the index spine level(s)
• Women of childbearing potential must practice adequate contraception
• Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Central Study Contacts

Wen Chi Yang

CONTACT

+886223123456; claireds23@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 10, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)