Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727584
• Other study ID #: CDR0000599886
• Secondary ID: CRUK-UCL-BRD-07-
• Status: Completed
• Phase: N/A
• First received: August 1, 2008
• Last updated: August 23, 2013
• Start date: November 2007
• Est. completion date: August 2009

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Compression
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Radiation:
• radiation therapy
Patients undergo external beam radiotherapy

Locations

Country	Name	City	State
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Christie Hospital	Manchester
United Kingdom	Cancer Research UK and University College London Cancer Trials Centre	Northwood	England
United Kingdom	Glan Clwyd Hospital	Rhyl, Denbighshire	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient accrual per center over a 12-month period			No
Secondary	Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline			No
Secondary	Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline			Yes
Secondary	Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment			Yes
Secondary	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			No
Secondary	Further treatment			No
Secondary	Overall survival at 3, 6, and 12 months			No
Secondary	Total number of days spent in hospital			No
Secondary	Preferred place of care			No
Secondary	Number of patients eligible but not randomized and reasons for non-randomization			No