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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Ronald McGarry, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01654068
First received: July 17, 2012
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Vertebral Metastasis
Radiation: Conformal High Dose Intensity Modulated Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Time to any skeletal related event [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression.


Secondary Outcome Measures:
  • Acute Radiation Toxicity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy)

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


Estimated Enrollment: 25
Study Start Date: December 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation Therapy 2-3 Spine metastases
Conformal High Dose Intensity Modulated Radiation Therapy
Radiation: Conformal High Dose Intensity Modulated Radiation Therapy
Conformal High Dose Intensity Modulated Radiation Therapy 14Gy single fraction dosing using 6MV photons
Experimental: Radiation Therapy solitary spine metastasis
Conformal High Dose Intensity Modulated Radiation Therapy
Radiation: Conformal High Dose Intensity Modulated Radiation Therapy
Conformal High Dose Intensity Modulated Radiation Therapy 14Gy single fraction dosing using 6MV photons

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654068

Contacts
Contact: Ronald McGarry, M.D. 859-323-6486 rcmcga2@email.uky.edu

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Principal Investigator: Ronald McGarry, M.D.         
Sponsors and Collaborators
Ronald McGarry
Investigators
Principal Investigator: Ronald McGarry, M.D. University of Kentucky
  More Information

No publications provided

Responsible Party: Ronald McGarry, Professor, Radiation Medicine, University of Kentucky
ClinicalTrials.gov Identifier: NCT01654068     History of Changes
Other Study ID Numbers: 09-RAD-01
Study First Received: July 17, 2012
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Female Breast Cancer
Kidney Cancer
Lung Cancer
Prostate Cancer
Vertebral metastasis

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014