Post Operative RT for Limited Spine Metastases

NCT ID: NCT05495399

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2027-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spondylectomy with Conventional RT

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

Group Type: EXPERIMENTAL

Spondylectomy

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Spondylectomy

Intervention Type: 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.

SBRT

Intervention Type: 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 SBRT

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

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: PROCEDURE

SBRT

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Wen Chi Yang

Role: CONTACT

claireds23@ntuh.gov.tw

+886223123456

Facility Contacts

Wen Chi Yang

Role: primary

claireds23@ntuh.gov.tw

+886223123456

Other Identifiers

202204039RINA

Identifier Type: -

Identifier Source: org_study_id