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.

Study Overview

• Status: Terminated
• Conditions: Vertebral Metastasis
• Intervention / Treatment: Radiation: Conformal High Dose Intensity Modulated Radiation Therapy

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Any Skeletal Related Event	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).	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Radiation Toxicity	The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy)	90 days
Late Radiation Toxicity	The number of late side effects of radiation therapy will be documented (> 90 days after the start of radiation therapy)	2 years

Collaborators and Investigators

• Sponsor: Ronald McGarry
• Investigators: Principal Investigator: Ronald McGarry, M.D., University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2009
• Primary Completion (Actual): April 22, 2016
• Study Completion (Actual): September 8, 2016

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (Estimate): July 31, 2012

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Lung Cancer; Prostate Cancer; Kidney Cancer; Female Breast Cancer; Vertebral metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: MCC-09-RAD-01

Drug and device information, study documents

• 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