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

NCT04375891 | Active Not Recruiting

• 1 other identifier: 2018-KOT-001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Spine Metastases

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months, 6, 12, 24 months

Secondary Outcomes (4)

• Change in pain response

  3 months, 6, 12, 24 months

• Measure increases in the duration of pain response

  3 months, 6, 12, 24 months

• Number of adverse events

  3 months, 6, 12, 24 months

• Measure the potential benefit on quality of life

  3 months, 6, 12, 24 months

Study Arms (2)

Radiotherapy

OTHER

Radiotherapy alone

Radiation: Radiation Therapy

Radiotherapy plus radiofrequency ablation

OTHER

Radiotherapy plus radiofrequency ablation / vertebral augmentation(Combination therapy)

Radiation: Radiation Therapy; Radiation: Radiofrequency Ablation (RFA)

Interventions

Radiation Therapy RADIATION

30 Gy in 10 fractions of 3 Gy each

Radiotherapy; Radiotherapy plus radiofrequency ablation

Radiofrequency Ablation (RFA) RADIATION

Radiofrequency Ablation (RFA) / Vertebral Augmentation

Radiotherapy plus radiofrequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baptist Health South Florida: lead
• Medtronic: collaborator

Study Sites (1)

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, 33176, United States

Location

Related Publications (1)

• 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.

  PMID: 33228756 DERIVED

Related Links

• Miami Cancer Institute website

MeSH Terms

Conditions

Neoplasms

Interventions

Radiotherapy; Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Therapeutics; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Rupesh Kotecha, MD

  Miami Cancer Institute (MCI) at Baptist Health South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: May 6, 2020
• Study Start: May 22, 2020
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

US (1)