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Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

Primary Purpose

Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
radiation therapy
Sponsored by
Cancer Research UK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Compression focused on measuring spinal cord compression, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bristol Haematology and Oncology Centre
  • Cancer Research UK and University College London Cancer Trials Centre
  • Glan Clwyd Hospital
  • Christie Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (multi-fraction radiotherapy)

Arm II (single-fraction radiotherapy)

Arm Description

Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.

Patients undergo 1 fraction of 8 Gy external beam radiotherapy.

Outcomes

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

Full Information

First Posted
August 1, 2008
Last Updated
August 23, 2013
Sponsor
Cancer Research UK
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1. Study Identification

Unique Protocol Identification Number
NCT00727584
Brief Title
Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression
Official Title
SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research UK

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
spinal cord compression, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (multi-fraction radiotherapy)
Arm Type
Active Comparator
Arm Description
Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
Arm Title
Arm II (single-fraction radiotherapy)
Arm Type
Experimental
Arm Description
Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
Patients undergo external beam radiotherapy
Primary Outcome Measure Information:
Title
Patient accrual per center over a 12-month period
Secondary Outcome Measure Information:
Title
Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Title
Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
Title
Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
Title
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
Title
Further treatment
Title
Overall survival at 3, 6, and 12 months
Title
Total number of days spent in hospital
Title
Preferred place of care
Title
Number of patients eligible but not randomized and reasons for non-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J. Hoskin, MD
Organizational Affiliation
Mount Vernon Cancer Centre at Mount Vernon Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Cancer Research UK and University College London Cancer Trials Centre
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 6UX
Country
United Kingdom

12. IPD Sharing Statement

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Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

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