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Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine

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ClinicalTrials.gov Identifier: NCT01654068
Recruitment Status : Terminated (low participant accrual)
First Posted : July 31, 2012
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ronald McGarry, University of Kentucky

Study Description
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Brief Summary:
The purpose of this study is to determine if Conformal High Dose Intensity Modulated Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal column. This study involves patients who have been diagnosed with metastatic cancer to the thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the area of concern. The goal is to prove that this is not only a safe form of treatment, but that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer coming back in the area that the investigators treat which may reduce the risk of developing symptoms like pain in the future.

Condition or disease Intervention/treatment Phase
Vertebral Metastasis Radiation: Conformal High Dose Intensity Modulated Radiation Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine
Actual Study Start Date : December 9, 2009
Actual Primary Completion Date : April 22, 2016
Actual Study Completion Date : September 8, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Radiation Therapy to Local Spine Metastasis
Conformal High Dose Intensity Modulated Radiation Therapy to a single asymptomatic local spine metastasis.
 Radiation: Conformal High Dose Intensity Modulated Radiation Therapy
Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons


Outcome Measures
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Primary Outcome Measures :
  1. Time to Any Skeletal Related Event [ Time Frame: up to 24 months ]
    Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival).


Secondary Outcome Measures :
  1. Acute Radiation Toxicity [ Time Frame: 90 days ]
    The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy)

  2. Late Radiation Toxicity [ Time Frame: 2 years ]
    The number of late side effects of radiation therapy will be documented (> 90 days after the start of radiation therapy)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological confirmation of malignancy (non-small cell lung cancer, breast cancer (hormone refractory), prostate cancer (hormone refractory), lymphoma, renal cell carcinoma, myeloma by either biopsy or cytology of the primary or metastatic lesion.
  • Patients must have radiological documentation of metastatic disease to the thoracic or lumbar spine including both positron emitted tomography (PET) or nuclear medicine bone scan (NMBS) and Magnetic Resonance Imaging (MRI) within 4 weeks prior to study entry.
  • Patients with one to three spinal metastases to the thoracic or lumbar spine will be included.
  • Spinal metastatic lesions should be limited to one vertebral body level or ≤ 6cm in greatest dimension.
  • Tumors should not directly abut the spinal cord, and have at least 5mm separation from the spinal cord. For patients with tumors closer than 5mm, inclusion is permissible at the discretion of the treating radiation oncologist such that dosimetric review demonstrates that the total dose to spinal cord is within tolerable range of <10Gy to 10% partial volume or max point dose 18 Gy.
  • Patients must be able to fit into either the Elekta Stereotactic Body Frame or the Elekta Stereotactic BodyFix immobilization device.
  • Must be ≥ 18 years of age.
  • ECOG status 0-2.
  • Women of childbearing potential and male participants must use an effective contraception method. (Until at least 60 days following treatment.)
  • Negative urine pregnancy test within at least one week before starting treatment in women of child-bearing age.
  • Patients must sign a study-specific informed consent form.

Exclusion Criteria:

  • Patients with evidence of spinal instability OR neurologic deficit resulting from bony compression of neurologic structures.
  • Patients with other systemic illness, or have not recovered adequately from their primary treatment or who have evidence of progression of their current cancer prior to therapy that, in the investigator's opinion, would preclude their inclusion.
  • Patient may not receive concomitant cytotoxic anti-neoplastic therapy during treatment. Patients may be allowed to use hormonal suppression therapy or bisphosphonates for hypercalcemia.
  • Pregnant or lactating women.
  • Any patient with symptoms of pain, compression fracture, neurologic deficit will not be included.
  • Patients previously treated with radiation therapy to the thoracic or lumbar spinal levels of involved disease will not be included.
Contacts and Locations
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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): NCT01654068


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Ronald McGarry
Investigators
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Principal Investigator: Ronald McGarry, M.D. University of Kentucky
  Study Documents (Full-Text)

Documents provided by Ronald McGarry, University of Kentucky:
Study Protocol and Statistical Analysis Plan  [PDF] June 27, 2013
Informed Consent Form  [PDF] June 24, 2013

More Information
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Responsible Party: Ronald McGarry, Professor, Radiation Medicine, University of Kentucky
ClinicalTrials.gov Identifier: NCT01654068    
Other Study ID Numbers: MCC-09-RAD-01
First Posted: July 31, 2012    Key Record Dates
Results First Posted: April 19, 2019
Last Update Posted: April 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ronald McGarry, University of Kentucky:
Female Breast Cancer
Kidney Cancer
Lung Cancer
Prostate Cancer
Vertebral metastasis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes