Condition category
Cancer
Date applied
10/07/2007
Date assigned
01/08/2007
Last edited
05/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Tim Iveson

ORCID ID

Contact details

The Beatson West of Scotland Cancer Centre
Level 4
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Additional identifiers

EudraCT number

2007-003957-10

ClinicalTrials.gov number

NCT00749450

Protocol/serial number

SCOT 2007-01

Study information

Scientific title

SCOT - Short Course Oncology Therapy: a study of adjuvant chemotherapy in colorectal cancer by the CACTUS and QUASAR 3 Groups

Acronym

SCOT - Short Course Oncology Therapy

Study hypothesis

The study aims to ascertain whether 3 months of treatment is as efficacious as 6 months with the further aim of providing robust evidence on the cost-effectiveness of reducing the duration of adjuvant therapy.

Please note that the overall trial start date has been updated from 31/03/2008 to 27/03/2008.

On 22/02/2011 the overall trial end date for this trial was updated from 01/04/2012 to 27/03/2013.

On 10/07/2014 the following changes were made to the trial record:
1. The anticipated end date was changed from 01/11/2014 to 30/11/2014.
2. The target number of participants was changed from 9500 to 6144.

Ethics approval

West Glasgow Ethics Committee 1, 21/01/2008, ref: 07/S08703/136. All other centres will seek ethics approval before recruitment of the first participant.

Study design

Open randomised controlled multi-centre non-inferiority trial incorporating a nested methodology study and an initial pilot period

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal cancer

Intervention

Control arm - 6 months of XELOX/FOLFOX chemotherapy
Experimental arm - 3 months of XELOX/FOLFOX chemotherapy

The treatment regimen will be either:
1. Oxaliplatin/capecitabine (XELOX), which is a 3 weekly cycle OR;
2. Oxaliplatin/5-fluorouracil (5 FU) (FOLFOX), which is a 2 weekly cycle

Depending on which arm the patient draws and which regimen they are given will establish the number of cycles, for example on the control arm receiving XELOX regimen patient would receive 8 cycles at 3 weekly intervals or if receiving FOLFOX regimen on control arm would receive 12 cycles at 2 weekly intervals.

The same would apply for the experimental arm, for example a patient receiving XELOX regimen would receive 4 cycles at 3 weekly intervals or if receiving FOLFOX regimen 6 cycles at 2 weekly intervals.

XELOX regimen dosage details: three weeks (21 day cycle) oxaliplatin 130 mg/m^2 intravenous (IV) over 2 hours on day one, capecitabine 1000 mg/m^2 on day 1 to day 14, twice daily (bid) (oral).

FOLFOX regimen dosage details: 2 weeks (14-day cycle) oxaliplatin 85 mg/m^2 IV over 2 hours on day 1, 5 FU 400 mg/m^2 on day 1 bolus injection, 5 FU 600 mg/m^2 on day 2 IV over 22 hours, 5 FU 400 mg/m^2 on day 3 bolus injection, 5 FU 600 mg/m^2 day 3 IV over 22 hours.

Clinical follow-up once treatment is complete will be monthly for 3 months (experimental arm only), 3 monthly until month 12 (end of year 1), 6-monthly until month 24 (end of year 2), then annually thereafter. The maximum duration of follow-up will be 7 years.

Intervention type

Drug

Phase

Not Applicable

Drug names

Oxaliplatin/capecitabine (XELOX), Oxaliplatin/5-fluorouracil (5 FU) (FOLFOX)

Primary outcome measures

Non-inferiority question:
Disease free survival (defined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause).

Timing of randomisation question:
Projected probability of study completing recruitment with at most a 4-month overrun.

Secondary outcome measures

Non-inferiority question:
1. Overall survival
2. Cost effectiveness
3. Toxicity
4. Quality of life

Timing of randomisation question:
Compliance rate with allocated treatment duration.

For the purposes of this study patients will be followed up with clinical examination and CEA at 3-monthly intervals until month 12 (end of year 1) then 6-monthly until month 24 (end of year 2). Computed Tomography (CT) scanning will be performed at six-monthly intervals for 2 years and colonoscopy per individual centre protocol. In years 3 to 5 patients will be reviewed at yearly intervals. Investigations will be performed at other times as clinically indicated.

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) questionnaire and EORTC QLQ-CR29 (a colorectal module) will be administered prior to randomisation and prior to each treatment cycle. In addition quality of life will be assessed monthly in the experimental arm (3-month arm) for the three months post treatment; there will be follow-up quality of life assessments in both arms at 9 and 12 months of study.

Neurotoxicity will be assessed at the same time points as quality of life using the Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group - Neurotoxicity (FACT/GOG Ntx) questionnaire.

In addition to the disease specific EORTC QOL questionnaires, the generic EuroQoL (EQ-5D) questionnaire will be employed to facilitate the calculation of quality of life utilities suitable for the economic analysis. This will be administered at the same frequency as the EORTC QOL questionnaires.

Overall trial start date

27/03/2008

Overall trial end date

30/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 10/07/2014:
1. Fully resected stage III colorectal cancer or high-risk stage II disease (defined as T4 disease, perforation, obstruction, less than 10 nodes examined, poorly differentiated histology or venous invasion)
2. No evidence of metastatic disease
3. Within 11 weeks of surgery
4. World Health Organisation Performance Status (WHO PS) equals zero or one
5. Greater than or equal to 18 years of age
6. Life expectancy greater than 5 years
7. Written informed consent
8. Normal Carcinoembryonic Antigen (CEA)
9. Patients with rectal cancer will be eligible unless they have had pre-op (chemotherapy) radiotherapy or are scheduled for post-op (chemotherapy) radiotherapy. Such patients must have had Total Mesorectal Excision (TME) surgery with negative (RO) resection margins

Previous inclusion criteria:
1. Fully resected stage III colorectal cancer or high-risk stage II disease (defined as T4 disease, perforation, obstruction, less than 10 nodes examined, poorly differentiated histology or venous invasion)
2. No evidence of metastatic disease
3. Within eight weeks of surgery
4. World Health Organisation Performance Status (WHO PS) equals zero or one
5. Greater than or equal to 18 years of age
6. Life expectancy greater than five years
7. Written informed consent
8. Normal Carcinoembryonic Antigen (CEA)
9. Patients with rectal cancer will be eligible unless they have had pre-op (chemotherapy) radiotherapy or are scheduled for post-op (chemotherapy) radiotherapy. Such patients must have had Total Mesorectal Excision (TME) surgery with negative (RO) resection margins

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6144

Participant exclusion criteria

1. Previous chemotherapy
2. Previous abdomino-pelvic radiotherapy
3. Moderate/severe renal impairment (Glomerular Filtration Rate [GFR] less than 30 ml/min)
4. Absolute neutrophil count less than 1.5 x 10^9
5. Platelet count less than 100 x 10^9
6. Haemoglobin less than 9 g/dl
7. Liver function tests greater than 2.5 Upper Limit of Normal (ULN)
8. Clinically significant cardiovascular disease
9. Pregnancy/lactation or of childbearing potential not using adequate contraception
10. Previous malignancy
11. Known Dihydropyrimidine Dehydrogenase (DPD) deficiency

In addition, for the 3-month randomisation point, only patients deemed to be fit to continue treatment will be randomised.

Recruitment start date

27/03/2008

Recruitment end date

29/11/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Beatson West of Scotland Cancer Centre
Glasgow
G12 0YN
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

Research and Development Central Office
The Tennent Institute
1st Floor
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom

Sponsor type

Government

Website

http://www.nhsggc.org.uk/r&d

Organisation

University of Glasgow

Sponsor details

University Avenue
Glasgow
G12 8QQ
United Kingdom

Sponsor type

University/education

Website

http://www.gla.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0601705)

Alternative name(s)

MRC

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