Condition category
Cancer
Date applied
12/05/2009
Date assigned
26/06/2009
Last edited
22/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Peter Hoskin

ORCID ID

Contact details

Marie Curie Research Wing
Mount Vernon Hospital
Rickmansworth Road
Northwood
Middlesex
HA6 2RN
United Kingdom
+44 1923 844 533
ctc.scorad@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00727584

Protocol/serial number

N/A

Study information

Scientific title

A randomised phase III trial of single fraction radiotherapy compared to multifraction radiotherapy in patients with metastatic spinal cord compression

Acronym

SCORAD III

Study hypothesis

This is a non-inferiority trial to show that ambulatory status using 8 Gy in one fraction is no worse than 20 Gy in five fractions.

On 01/03/2011 the anticipated end date for this trial was changed from 01/09/2014 to 14/07/2015.

Ethics approval

North West London REC 1, 03/11/2009, ref: 09/H0722/76

Study design

Multicentre randomised phase III trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at: http://www.ucl.ac.uk/cancertrials/trials/scorad/SCORAD%20summary%20April%2007.pdf

Condition

Metastatic spinal cord compression

Intervention

Patient randomisation is performed using a 24 hour remote internet based randomisation programme.

Arm 1: External beam multi-fraction radiotherapy: 20Gy/5f
Arm 2: External beam single fraction radiotherapy: 8Gy/1f

Total duration of treatment is approximately one week for Arm 1, and one day for Arm 2.
Follow up for both treatment arms is at 1, 4, 8 and 12 weeks after day 1 of treatment.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Ambulatory status is determined through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at 8 weeks from day 1 of treatment compared to randomisation.

Secondary outcome measures

1. Recovery of and time to ambulation is measured through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at weeks 1, 4, 8, and 12 from day 1 of treatment compared to randomisation
2. Ambulatory status is determined using measured through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at 1, 4, and 12 weeks (where available) compared to randomisation
3. Maintenance of ambulatory status is determined through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying a simple 4 point ambulatory scale at weeks 1, 4, 8, and 12 from day 1 of treatment compared to randomisation
4. Bladder and bowel function is measured through phone interviews with the patient or where this is not possible, reviewing the patient notes, at 1, 4, 8 and 12 weeks from day 1 of treatment compared to randomisation
5. Acute side effects are measured using through phone interviews with the patient or where this is not possible, reviewing the patient notes, applying the Common Terminology Criteria for Adverse Events (CTCAE) scales v4.02 or Radiation Treatment and Oncology Groups (RTOG) Scales at 1, 4, 8 and 12 weeks from day 1 of treatment
6. Quality of life is measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-30) questionnaire at 1, 4, 8 and 12 weeks from day 1 of treatment compared to randomisation. This is either posted to the patient from UCT CTC or administered by the hospital trial team if the patient is an inpatient.
7. Further treatment is recorded using through phone interviews with the patient or where this is not possible, reviewing the patient notes, at 1, 4, 8 and 12 weeks and 12 months from day 1 of treatment
8. Duration of care in hospital, hospice, nursing home or home is determined through phone interviews with the patient or where this is not possible, reviewing the patient notes at 1, 4, 8 and 12 weeks
9. Preferred place of care is determined through phone interviews with the patient at 1, 4, 8 and 12 weeks from day 1 of treatment
10. Overall survival is determined at 12 and 52 weeks through review of patient notes. Alternatively the trial is flagged with the UK Health & Social Care Information Centre for survival data

Overall trial start date

01/09/2009

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria as of 04/02/2016:
1. Decision to treat made no more than 48 hours prior to treatment of spinal cord or cauda equina (C1 to S2) compression, based on a full spinal MRI or CT scan confirming compression carried out no more than one week prior to treatment
2. Single site of compression or multiple sites that can be treated within a single radiation treatment field
3. Histologically or cytologically confirmed malignant disease, or for prostate tumours a serum PSA >100 ng/ml at any point prior to randomisation (if biopsy done or planned but results not yet available patients may be entered provided all other inclusion and exclusion criteria are met. Biopsy results must be submitted on the relevant CRF page as soon as they are available)
4. Life expectancy greater than 8 weeks
5. Age greater than or equal to 18 years, either sex
6. Able to give informed consent
7. Willing and able to complete assessment forms

Original inclusion criteria:
1. Proven diagnosis of spinal cord compression on magnetic resonance imaging (MRI) or computed tomography (CT) scan
2. Single site of compression or multiple sites that can be treated within a single radiation treatment field
3. Histologically or cytologically confirmed malignant disease, or for prostate tumours serum prostate specific antigen (PSA) at diagnosis of greater than 100 ng/ml
4. Life expectancy greater than 8 weeks
5. Age greater than or equal to 18 years, either sex
6. Able to give informed consent
7. Willing and able to complete assessment forms

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

700

Participant exclusion criteria

Exclusion criteria as of 04/02/2016:
1. Patients for whom surgery or chemotherapy treatment is more appropriate
2. Patients with multiple myeloma, lymphoma, leukaemia or glioma
3. Patients who are known to be pregnant
4. Patients undergoing purely prophylactic treatment in the absence of radiological spinal cord or cauda equina compression
5. Patients whose spinal compression site has been treated previously with radiotherapy

Original exclusion criteria:
1. Patients for whom surgery or chemotherapy treatment is more appropriate
2. Patients with multiple myeloma or lymphoma
3. Patients who are known to be pregnant
4. Patients undergoing purely prophylactic treatment for early onset spinal cord compression
5. Patients undergoing treatment for compression affecting the spinal canal below L1

Recruitment start date

01/09/2009

Recruitment end date

30/04/2016

Locations

Countries of recruitment

Australia, United Kingdom

Trial participating centre

Cancer Research UK & UCL Cancer Trials Centre
University College London 90 Tottenham Court Road
London
W1T 4TJ
United Kingdom

Trial participating centre

Mater Health Services
Raymond Terrace
Brisbane
QLD 4101
Australia

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

c/o Nick McNally
Divisional Manager
Joint UCLH and UCL Biomedical Research Unit (1st Floor
Maple House)
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 5DB
United Kingdom
+44 (0)20 7380 9825
ctc.scorad@ucl.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C2422/A11408)

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

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/03/2016: The Australian trial participating centre (Mater centre) has been added, as well as the methods of measurement used to measure each of the outcome measures. In addition, the availability of the participant level data has been added. 04/02/2016: The overall trial end date has been updated from 01/09/2014 to 30/04/2017 and the recruitment end date has been updated from 14/07/2015 to 30/04/2016. In addition, the inclusion and exclusion criteria have been updated and the trial participating centre has been changed from the Marie Curie Research Wing to Cancer Research UK & UCL Cancer Trials Centre.