Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anand Mahadevan, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01525745
First received: December 13, 2011
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine how effective SBRT is compared to traditional radiation in treating the cancer that has spread to your spine and is causing pain. SBRT is delivered at a higher dose for a shorter period of time when compared to standard radiation therapy and the aim is to see if there will be an improvement both in pain control and your cancer It is not known whether SBRT is better or worse than current standard therapy. If you are selected to receive the experimental treatment in this research study, SBRT uses highly focused x-rays that deliver a single high dose to a specific area of the spine compared to conventional standard radiation over a period of 10 days which has been the standard proven treatment to help your condition. The investigators will also determine which treatment provides the most rapid pain relief with the least side effects. It is possible that SBRT may not be better or could be more toxic. The investigators will conduct quality of life assessments and pain scale index to assess how you are feeling once you have had the intervention.


Condition Intervention Phase
Primary Tumor
Metastatic Cancer
Radiation: Radiosurgery/SBRT
Radiation: External Beam Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Ph II Study of Stereotactic Body Radiotherapy (SBRT) Versus Conventional Radiation for Spine Metastasis

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Pain Control as measured by NPRS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy


Secondary Outcome Measures:
  • Duration of pain response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Determine whether image-guided radiosurgery/SBRT increases the duration of pain response at the treated site(s), as compared to conventional external beam radiotherapy, as measured by NPRS

  • Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Compare adverse events between the two treatments according to the criteria in the CTEP Active Version of CTCAE

  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life as measured by FACT-G, BPI and EQ-5D

  • Long Term Effects of image-guided radiosurgery/SBRT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord

  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Progrsesion Free and Overall Survival


Estimated Enrollment: 81
Study Start Date: January 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiosurgery/SBRT
Radiosurgery/SBRT
Radiation: Radiosurgery/SBRT
1, 3 or 5 SBRT treatments
Active Comparator: External Beam Radiation Therapy
External Beam Radiation Therapy
Radiation: External Beam Radiation Therapy
10 consecutive days of standard radiation

Detailed Description:

Randomization means that you are put into a group by chance. It is like flipping a coin. Neither you nor the research doctor will choose what group you will be in.

You will have a 2 to 1 chance of being placed in the SBRT to standard radiation group. Since SBRT is the newer treatment being tested, we would like to include more patients in this group.

Treatment Procedures:

SBRT: You may receive one, three or five SBRT treatments depending on the extent of your cancer. During each treatment you will be assessed by a nurse and a physician for a physical and neurological assessment. The treatment itself would last approximately I hour where you will be lying on a treatment table. Prior to each treatment you will have a physical and neurological assessment by a physician. Standard Radiation: You will receive ten consecutive working days of standard radiation. While each treatment lasts five to ten minutes, the entire visit may last up to thirty minutes. During the treatment you will be lying on a treatment table. Once per week you will have a physical and neurological assessment by your treating physician After the final treatment of the study therapy: We would like to keep track of your medical condition for at least 12 months after you receive treatment. We would like to do this by having you come in to the clinic at months 1, 3, 6, 12 and 24 months after treatment*. At these visits we will be looking for the same information as during the screening time frame. This includes:

  • A history and physical from you
  • A Performance Status of how you are able to carry on with your usual activities.
  • A Pain scale questionnaire called the Numerical Rating Pain Scale(NRPS) that asks to explain your pain symptoms on a 0-10 scale
  • 3 Quality Of Life (QOL) Assessments described below:
  • Functional Assessment of Cancer Therapy-General (FACT-G)
  • The Brief Pain Inventory (BPI)
  • The EuroQOL (EQ-5D)
  • An assessment of your tumor by MRI (Magnetic Resonance Imaging)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed primary tumor or metastatic cancer with radiological diagnosis of spine metastasis
  • The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study
  • Zubrod Performance Status 0-2
  • History/physical examination within 2 weeks prior to registration
  • Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential
  • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • MRI of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement
  • Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the Scale of >5 for at least one of the planned sites for spine radiosurgery. Patients taking medication for pain at the time of registration are eligible.
  • Neurological examination within 1 week prior to registration to rule out rapid neurologic decline

Exclusion Criteria:

  • Histology of myeloma, lymphoma or germ cell tumors.
  • Non-ambulatory patients
  • Spine instability due to a compression fracture
  • > 50% loss of vertebral body height
  • Frank spinal cord displacement or epidural involvement with> 25% encirclement of cord or >25% spinal canal involvement.
  • Prior radiation to the index spine
  • Patients for whom an MRI of the spine is medically contraindicated
  • Uncontrolled intercurrent illness
  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: NCT01525745

Locations
United States, Massachusetts
Beth Israel Deacness Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Anand Mahadevan, M.D. Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Anand Mahadevan, Principle Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01525745     History of Changes
Other Study ID Numbers: 10-294
Study First Received: December 13, 2011
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014