Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04375891
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : January 18, 2023
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Baptist Health South Florida

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Oncology Spine Metastases Radiation: Radiation Therapy Radiation: Radiofrequency Ablation (RFA) Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Randomized Phase II Study of Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation for Localized Spine Metastasis
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : May 2026
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Radiotherapy
Radiotherapy alone
 Radiation: Radiation Therapy
30 Gy in 10 fractions of 3 Gy each
Radiotherapy plus radiofrequency ablation
Radiotherapy plus radiofrequency ablation / vertebral augmentation(Combination therapy)
 Radiation: Radiation Therapy
30 Gy in 10 fractions of 3 Gy each

Radiation: Radiofrequency Ablation (RFA)
Radiofrequency Ablation (RFA) / Vertebral Augmentation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in pain control [ Time Frame: 3 months, 6, 12, 24 months ]
    Change in pain control (as measured by the 11 point Numeric pain rating scale) as compared to conventional palliative radiotherapy alone.


Secondary Outcome Measures :
  1. Change in pain response [ Time Frame: 3 months, 6, 12, 24 months ]
    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.

  2. Measure increases in the duration of pain response [ Time Frame: 3 months, 6, 12, 24 months ]
    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.

  3. Number of adverse events [ Time Frame: 3 months, 6, 12, 24 months ]
    Number of adverse events between the two treatments according to the NCI Common Terminology Criteria for Adverse Events version 5.0.

  4. Measure the potential benefit on quality of life [ Time Frame: 3 months, 6, 12, 24 months ]
    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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375891


Contacts
Layout table for location contacts
Contact: Rupesh Kotecha, MD 786-596-2000 RupeshK@baptisthealth.net

Locations
Layout table for location information
United States, Florida
Miami Cancer Institute at Baptist Health South Florida Recruiting
Miami, Florida, United States, 33176
Contact: Rupesh Kotecha, MD    786-527-7642    RupeshK@baptisthealth.net   
Principal Investigator: Rupesh Kotecha, MD         
Sponsors and Collaborators
Baptist Health South Florida
Medtronic
Investigators
Layout table for investigator information
Principal Investigator: Rupesh Kotecha, MD Miami Cancer Institute (MCI) at Baptist Health South Florida
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT04375891    
Other Study ID Numbers: 2018-KOT-001
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes