Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00727584
First received: August 1, 2008
Last updated: August 23, 2013
Last verified: June 2009
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patient accrual per center over a 12-month period [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline [ Designated as safety issue: No ]
  • Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline [ Designated as safety issue: Yes ]
  • Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment [ Designated as safety issue: Yes ]
  • 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 [ Designated as safety issue: No ]
  • Further treatment [ Designated as safety issue: No ]
  • Overall survival at 3, 6, and 12 months [ Designated as safety issue: No ]
  • Total number of days spent in hospital [ Designated as safety issue: No ]
  • Preferred place of care [ Designated as safety issue: No ]
  • Number of patients eligible but not randomized and reasons for non-randomization [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00727584     History of Changes
Other Study ID Numbers: CDR0000599886, CRUK-UCL-BRD-07-010, CRUK-SCORAD, ISRCTN97555949, EU-20863
Study First Received: August 1, 2008
Last Updated: August 23, 2013
Health Authority: Unspecified

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

ClinicalTrials.gov processed this record on July 29, 2014