Condition category
Cancer
Date applied
04/06/2007
Date assigned
23/07/2007
Last edited
08/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Peter J Hoskin

ORCID ID

Contact details

Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
Middlesex
Northwood
HA6 2RN
United Kingdom
+44 (0)1923 844533
peterhoskin@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00727584

Protocol/serial number

BRD/07/010

Study information

Scientific title

A randomised feasibility study of single fraction radiotherapy compared to multi-fraction radiotherapy in patients with metastatic spinal cord compression

Acronym

SCORAD feasibility study

Study hypothesis

To examine whether a phase III randomised trial comparing a single fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and patients.

As of 29/04/2008 the anticipated start and end dates of this trial were updated. The initial anticipated start and end dates of this trial were:
Anticipated start date: 11/11/2007
Anticipated end date: 11/11/2008

As of 12/05/2009 the anticipated end date of this trial was again extended; the previous anticipated end date was 21/02/2009.

Ethics approval

Cornwall and Plymouth Research Ethics Committee approved before patient recruitment began (ref: 07/H0203/167)

Study design

Randomised controlled feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Metastatic spinal cord compression

Intervention

Radiotherapy (single or multiple fractions):
Arm 1: 20 Gy/5 fractions daily for 5 consecutive days
Arm 2: 8 Gy/1 fraction

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patient accrual per centre over a 12-month period.

Secondary outcome measures

1. Ambulatory status at 1, 4, 8 and 12 weeks from day 1 of treatment compared to baseline
2. Bladder and bowel function at baseline compared to week 1, 4, 8 and 12
3. Acute side effects at week 1 and 4 assessed using Radiation Therapy Oncology Group (RTOG) scales
4. Quality of life at week 1, 4, 8 and 12, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) questionnaire
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 who were eligible but not randomised and reasons for non-randomisation

Overall trial start date

01/03/2008

Overall trial end date

31/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Proven diagnosis of spinal cord compression on magnetic resonance imaging (MRI)
2. Histologically or cytologically confirmed malignant disease
3. Life expectancy greater than 1 month
4. Aged 18 years or older
5. Able to give informed consent
6. Willing and able to complete assessment forms

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients for whom surgery or chemotherapy treatment is more appropriate
2. Patient known to be pregnant

Recruitment start date

01/03/2008

Recruitment end date

31/08/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Marie Curie Research Wing
Northwood
HA6 2RN
United Kingdom

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

Medical School Administration
Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/cancertrials/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C2422/A7932)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes