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

Vertebral Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01654068
• Other study ID #: MCC-09-RAD-01
• Status: Terminated
• Phase: N/A
• Start date: December 9, 2009
• Est. completion date: September 8, 2016

Study information

• Verified date: March 2019
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 8, 2016
• Est. primary completion date: April 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Vertebral Metastasis

Intervention

Radiation:
• Conformal High Dose Intensity Modulated Radiation Therapy
Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Ronald McGarry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute Radiation Toxicity	The number of acute side effects of radiation therapy will be documented (= 90 days from start of radiation therapy)	90 days
Secondary	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