Post Operative RT for Limited Spine Metastases

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05495399
• Collaborator: (none)
• Enrollment: 111
• Arms: 3
• Anticipated Duration (Months): 59

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spine Metastases	Procedure: Spondylectomy; Radiation: SBRT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2026
• Anticipated Study Completion Date: Jul 1, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Local control [12 months post surgery]

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

Secondary Outcome Measures

1. Overall survival [12 months post surgery]

   Survival from treatment to death

2. pain control [Every 3 months up to 1 year post surgery]

   using numerical pain score to assess pain

3. Quality of life assessment [Every 3 months up to 1 year post surgery]

   EORTC QLQ-C15 PAL

4. Quality of life assessment [pre surgery and 1 month after surgery]

   Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0)

5. Quality of life assessment [Every 3 months up to 1 year post surgery]

   EORTC QLQ-BM22

6. Treatment related toxicity [Every 3 months up to 1 year post surgery]

   Using Common Terminology Criteria for Adverse Events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

6. Uncontrolled active infection requiring intravenous antibiotics at the time of registration

7. Transmural myocardial infarction ≤ 6 months prior to registration.

8. Life-threatening uncontrolled clinically significant cardiac arrhythmias.

9. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.

10. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.

11. Uncontrolled psychiatric disorder.

12. Pregnant or breast-feeding women

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05495399
• Other Study ID Numbers: 202204039RINA
• First Posted: Aug 10, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital: Stereotactic body radiotherapy; Spondylectomy; Separation surgery
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Aug 12, 2022