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

This study is currently recruiting participants.
Verified July 2012 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT01654068
First received: July 17, 2012
Last updated: July 30, 2012
Last verified: July 2012

July 17, 2012
July 30, 2012
December 2009
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01654068 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
 
 
 
Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine
Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine

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.

 
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Vertebral Metastasis
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 2-3 Spine metastases
    Conformal High Dose Intensity Modulated Radiation Therapy
    Intervention: Radiation: Conformal High Dose Intensity Modulated Radiation Therapy
  • Experimental: Radiation Therapy solitary spine metastasis
    Conformal High Dose Intensity Modulated Radiation Therapy
    Intervention: Radiation: Conformal High Dose Intensity Modulated Radiation Therapy
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
December 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Ronald McGarry, M.D. 859-323-6486 rcmcga2@email.uky.edu
United States
 
NCT01654068
09-RAD-01
Yes
University of Kentucky
University of Kentucky
 
Principal Investigator: Ronald McGarry, M.D. University of Kentucky
University of Kentucky
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP