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Completed

NCT Number: NCT00727584

Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Patients undergo external beam radiotherapy

Primary outcomes

  1. Patient accrual per center over a 12-month period

Secondary outcomes

  1. Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline

  2. Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline

  3. Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment

  4. 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

  5. Further treatment

  6. Overall survival at 3, 6, and 12 months

  7. Total number of days spent in hospital

  8. Preferred place of care

  9. Number of patients eligible but not randomized and reasons for non-randomization

Sponsors and collaborators

Lead sponsor

Cancer Research UK

Other

Registry information

Official study title

SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 4, 2008
Registry last updated
Aug 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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