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

NCT01654068 | Terminated Results DMC FDA Device

• 1 other identifier: MCC-09-RAD-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Metastasis

Keywords

Female Breast Cancer; Kidney Cancer; Lung Cancer; Prostate Cancer; Vertebral metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acute Radiation Toxicity

  90 days

• Late Radiation Toxicity

  2 years

Study Arms (1)

Radiation Therapy to Local Spine Metastasis

EXPERIMENTAL

Conformal High Dose Intensity Modulated Radiation Therapy to a single asymptomatic local spine metastasis.

Radiation: Conformal High Dose Intensity Modulated Radiation Therapy

Interventions

Conformal High Dose Intensity Modulated Radiation Therapy RADIATION

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

Radiation Therapy to Local Spine Metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients with evidence of spinal instability OR neurologic deficit resulting from bony compression of neurologic structures.
• 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.

Sponsors & Collaborators

• Ronald McGarry: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Lung Neoplasms; Prostatic Neoplasms

Interventions

Molecular Conformation; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Ronal McGarry
• Organization: University of Kentucky

rcmcga2@email.uky.edu

859-323-6486

Study Officials

• Ronald McGarry, M.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Radiation Medicine

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 31, 2012
• Study Start: December 9, 2009
• Primary Completion: April 22, 2016
• Study Completion: September 8, 2016
• Last Updated: April 19, 2019
• Results First Posted: April 19, 2019

Record last verified: 2019-03

Locations

US (1)