We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00727584
First Posted: August 4, 2008
Last Update Posted: August 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression.

PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.


Condition Intervention
Spinal Cord Compression Unspecified Adult Solid Tumor, Protocol Specific Radiation: radiation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Patient accrual per center over a 12-month period

Secondary Outcome Measures:
  • Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
  • Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
  • Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
  • Quality of life as measured by the EORTC QLQ-C30 questionnaire at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
  • Further treatment
  • Overall survival at 3, 6, and 12 months
  • Total number of days spent in hospital
  • Preferred place of care
  • Number of patients eligible but not randomized and reasons for non-randomization

Estimated Enrollment: 100
Study Start Date: November 2007
Study Completion Date: August 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (multi-fraction radiotherapy)
Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
Radiation: radiation therapy
Patients undergo external beam radiotherapy
Experimental: Arm II (single-fraction radiotherapy)
Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
Radiation: radiation therapy
Patients undergo external beam radiotherapy

Detailed Description:

OBJECTIVES:

  • To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression.
  • To determine the feasibility of conducting this study in the United Kingdom.

OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease [spinal metastases only vs spinal and non-bony metastases]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
  • Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy.

Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed malignant disease
  • Proven diagnosis of metastatic spinal cord compression on MRI or CT scan

    • Single site of compression OR multiple sites that can be treated within a single radiation treatment field
  • No patient for whom surgery or chemotherapy treatment is more appropriate
  • No multiple myeloma as primary cancer

PATIENT CHARACTERISTICS:

  • Life expectancy > 1 month
  • Not pregnant
  • Willing and able to complete assessment forms
  • Able to give informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727584


Locations
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Cancer Research UK and University College London Cancer Trials Centre
Northwood, England, United Kingdom, HA6 2RN
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Christie Hospital
Manchester, United Kingdom, M20 6UX
Sponsors and Collaborators
Cancer Research UK
Investigators
Principal Investigator: Peter J. Hoskin, MD Mount Vernon Cancer Centre at Mount Vernon Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00727584     History of Changes
Other Study ID Numbers: CDR0000599886
CRUK-UCL-BRD-07-010
CRUK-SCORAD
ISRCTN97555949
EU-20863
First Submitted: August 1, 2008
First Posted: August 4, 2008
Last Update Posted: August 26, 2013
Last Verified: June 2009

Keywords provided by National Cancer Institute (NCI):
spinal cord compression
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Spinal Cord Compression
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries