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Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation

Primary Purpose

Oncology, Spine Metastases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Radiofrequency Ablation (RFA)
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oncology

Eligibility Criteria

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

Inclusion Criteria:

  • The patient must have localized spine metastasis from the T5 to L5 levels by an imaging study (bone scan, PET, CT, or MRI). Patients can have other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible.
  • Zubrod Performance Status 0-3
  • History/physical examination within 2 weeks prior to registration
  • Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control;
  • MRI (contrast is not required but strongly recommended) of the involved spine within 6 weeks prior to registration to determine the extent of the spine involvement;
  • Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the Scale of ≥ 5 for at least one of the planned sites for intervention. Documentation of the patient's initial pain score is required. Patients taking medication for pain at the time of registration are eligible.
  • Patients with epidural compression are eligible provided that there is a ≥ 3 mm gap between the spinal cord and the edge of the epidural lesion.
  • Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

  • Histologies of myeloma, lymphoma, small-cell lung cancer, germ-cell tumor
  • Non-ambulatory patients;
  • Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord;
  • Patients with rapid neurologic decline;
  • Bony retropulsion causing neurologic abnormality;
  • Prior radiation to the index spine
  • Patients requiring immediate neurosurgical intervention
  • Patients receiving concurrent chemotherapy
  • Patients needing palliative to more than 2 sites of spinal disease in total

Sites / Locations

  • Miami Cancer Institute at Baptist Health South FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Radiotherapy

Radiotherapy plus radiofrequency ablation

Arm Description

Radiotherapy alone

Radiotherapy plus radiofrequency ablation / vertebral augmentation(Combination therapy)

Outcomes

Primary Outcome Measures

Change in pain control
Change in pain control (as measured by the 11 point Numeric pain rating scale) as compared to conventional palliative radiotherapy alone.

Secondary Outcome Measures

Change in pain response
Change in the rapidity of pain response at the treated site(s) as compared to conventional Radiotherapy alone, as measured by the Numeric pain rating scale.
Measure increases in the duration of pain response
Measure increases in the duration of pain response at the treated site(s), as compared to conventional RT alone, as measured by the Numeric pain rating scale.
Number of adverse events
Number of adverse events between the two treatments according to the NCI Common Terminology Criteria for Adverse Events version 5.0.
Measure the potential benefit on quality of life
Measure the potential benefit of radiotherapy plus Vertebral Augmentation/Radiofrequency Ablation on change in and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-General; in pain as measured by the Brief Pain Inventory; and in health utilities as measured by the EuroQol

Full Information

First Posted
March 13, 2020
Last Updated
January 17, 2023
Sponsor
Baptist Health South Florida
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT04375891
Brief Title
Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation
Official Title
Randomized Phase II Study of Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation for Localized Spine Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The spread of cancer to the spine is referred to as spine metastasis. Spine metastases are a common complication of cancer and are frequently associated with significant back pain. This study is being done to help improve treatment for back pain caused by spinal metastases by comparing the effectiveness of two standard treatments. These two treatments include radiation therapy (RT) alone versus radiation therapy combined with radiofrequency ablation, with or without vertebral augmentation (PVA/RFA). In addition to RT or RT with PVA/RFA, will be continued with current pain medications.
Detailed Description
All supportive therapy for optimal medical care will be given during the study period at the discretion of the attending physician(s) within the parameters of the protocol and documented on each site's source documents as concomitant medication. The study will be adequately powered with 52 patients (35 in the RT plus PVA/RFA arm and 17 in the RT arm). Assuming a 5% ineligibility rate, a death rate of 15%, and a patient non-compliance rate of 15%, the total sample size required would be 80 patients. Patients will be stratified according to the tumor type (radioresistant [soft tissue sarcoma, melanoma, and renal cell carcinoma] versus other types). The treatment allocation scheme described by Zelen (1974) will be used because it balances patient factors. Within each stratum, patients will be randomized in a 2:1 ratio to either image-guided RT plus RFA/PVA or external beam RT alone. The 2:1 randomization allocation will be used to accommodate increased demand for image-guided RT plus RFA/PVA.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A study design of 2:1 randomization scheme (RT plus PVA/RFA:RT), the study will be adequately powered with 52 patients (35 in the RT plus PVA/RFA arm and 17 in the RT arm). Assuming a 5% ineligibility rate, a death rate of 15%, and a patient non-compliance rate of 15%, the total sample size required would be 80 patients.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy
Arm Type
Other
Arm Description
Radiotherapy alone
Arm Title
Radiotherapy plus radiofrequency ablation
Arm Type
Other
Arm Description
Radiotherapy plus radiofrequency ablation / vertebral augmentation(Combination therapy)
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
30 Gy in 10 fractions of 3 Gy each
Intervention Type
Radiation
Intervention Name(s)
Radiofrequency Ablation (RFA)
Intervention Description
Radiofrequency Ablation (RFA) / Vertebral Augmentation
Primary Outcome Measure Information:
Title
Change in pain control
Description
Change in pain control (as measured by the 11 point Numeric pain rating scale) as compared to conventional palliative radiotherapy alone.
Time Frame
3 months, 6, 12, 24 months
Secondary Outcome Measure Information:
Title
Change in pain response
Description
Change in the rapidity of pain response at the treated site(s) as compared to conventional Radiotherapy alone, as measured by the Numeric pain rating scale.
Time Frame
3 months, 6, 12, 24 months
Title
Measure increases in the duration of pain response
Description
Measure increases in the duration of pain response at the treated site(s), as compared to conventional RT alone, as measured by the Numeric pain rating scale.
Time Frame
3 months, 6, 12, 24 months
Title
Number of adverse events
Description
Number of adverse events between the two treatments according to the NCI Common Terminology Criteria for Adverse Events version 5.0.
Time Frame
3 months, 6, 12, 24 months
Title
Measure the potential benefit on quality of life
Description
Measure the potential benefit of radiotherapy plus Vertebral Augmentation/Radiofrequency Ablation on change in and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-General; in pain as measured by the Brief Pain Inventory; and in health utilities as measured by the EuroQol
Time Frame
3 months, 6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must have localized spine metastasis from the T5 to L5 levels by an imaging study (bone scan, PET, CT, or MRI). Patients can have other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible. Zubrod Performance Status 0-3 History/physical examination within 2 weeks prior to registration Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control; MRI (contrast is not required but strongly recommended) of the involved spine within 6 weeks prior to registration to determine the extent of the spine involvement; Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the Scale of ≥ 5 for at least one of the planned sites for intervention. Documentation of the patient's initial pain score is required. Patients taking medication for pain at the time of registration are eligible. Patients with epidural compression are eligible provided that there is a ≥ 3 mm gap between the spinal cord and the edge of the epidural lesion. Patients must provide study specific informed consent prior to study entry. Exclusion Criteria: Histologies of myeloma, lymphoma, small-cell lung cancer, germ-cell tumor Non-ambulatory patients; Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord; Patients with rapid neurologic decline; Bony retropulsion causing neurologic abnormality; Prior radiation to the index spine Patients requiring immediate neurosurgical intervention Patients receiving concurrent chemotherapy Patients needing palliative to more than 2 sites of spinal disease in total
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rupesh Kotecha, MD
Phone
786-596-2000
Email
RupeshK@baptisthealth.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, MD
Organizational Affiliation
Miami Cancer Institute (MCI) at Baptist Health South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Cancer Institute at Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, MD
Phone
786-527-7642
Email
RupeshK@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33228756
Citation
Kotecha R, Schiro BJ, Sporrer J, Rubens M, Appel HR, Calienes KS, Boulanger B, Pujol MV, Suarez DT, Pena A, Kudryashev A, Mehta MP. Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial. Trials. 2020 Nov 23;21(1):964. doi: 10.1186/s13063-020-04895-x.
Results Reference
derived
Links:
URL
http://baptisthealth.net/cancer-care/home
Description
Miami Cancer Institute website

Learn more about this trial

Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation

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