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Post Operative RT for Limited Spine Metastases

Primary Purpose

Spine Metastases

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Spondylectomy

SBRT

About this trial

This is an interventional treatment trial for Spine Metastases focused on measuring Stereotactic body radiotherapy, Spondylectomy, Separation surgery

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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:
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.
Pregnant or breast-feeding women

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Spondylectomy with Conventional RT

Debulking surgery with Conventional RT

Debulking surgery with SBRT

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Local control

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

Secondary Outcome Measures

Overall survival

Survival from treatment to death

pain control

using numerical pain score to assess pain

Quality of life assessment

EORTC QLQ-C15 PAL

Quality of life assessment

Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0)

Quality of life assessment

EORTC QLQ-BM22

Treatment related toxicity

Using Common Terminology Criteria for Adverse Events

Full Information

NCT ID

NCT05495399

First Posted

August 4, 2022

Last Updated

August 10, 2022

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05495399

Brief Title

Post Operative RT for Limited Spine Metastases

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 2022 (Anticipated)

Primary Completion Date

July 2026 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spine Metastases

Keywords

Stereotactic body radiotherapy, Spondylectomy, Separation surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

111 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Spondylectomy with Conventional RT

Arm Type

Experimental

Arm Description

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

Arm Title

Debulking surgery with Conventional RT

Arm Type

Active Comparator

Arm Description

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

Arm Title

Debulking surgery with SBRT

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Spondylectomy

Intervention Description

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

Radiation

Intervention Name(s)

SBRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Local control

Description

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

Time Frame

12 months post surgery

Secondary Outcome Measure Information:

Title

Overall survival

Description

Survival from treatment to death

Time Frame

12 months post surgery

Title

pain control

Description

using numerical pain score to assess pain

Time Frame

Every 3 months up to 1 year post surgery

Title

Quality of life assessment

Description

EORTC QLQ-C15 PAL

Time Frame

Every 3 months up to 1 year post surgery

Title

Quality of life assessment

Description

Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0)

Time Frame

pre surgery and 1 month after surgery

Title

Quality of life assessment

Description

EORTC QLQ-BM22

Time Frame

Every 3 months up to 1 year post surgery

Title

Treatment related toxicity

Description

Using Common Terminology Criteria for Adverse Events

Time Frame

Every 3 months up to 1 year post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wen Chi Yang

Phone

+886223123456

claireds23@ntuh.gov.tw

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD sharing required by other researchers will be discussed in institution

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Post Operative RT for Limited Spine Metastases

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