Additional identifiers
EudraCT/CTIS number
2007-003957-10
IRAS number
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.
Ethics approval(s)
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 randomized 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
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Participating information sheet no longer available
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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Oxaliplatin/capecitabine (XELOX), Oxaliplatin/5-fluorouracil (5 FU) (FOLFOX)
Primary outcome measure
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 study start date
01/08/2005
Overall study end date
30/11/2017
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
6144
Total final enrolment
6088
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
09/05/2008
Recruitment end date
29/11/2013
Locations
Countries of recruitment
Scotland, United Kingdom
Study participating centre
The Beatson West of Scotland Cancer Centre
Glasgow
G12 0YN
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow and Clyde
Sponsor details
Research and Development Central Office
The Tennent Institute
1st Floor
Western Infirmary
38 Church Street
Glasgow
G11 6NT
Scotland
United Kingdom
Sponsor type
Government
Website
ROR
Organisation
University of Glasgow
Sponsor details
University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: G0601705)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Publications to a high-impact peer reviewed journal have recently been submitted, awaiting outcome. Once the primary paper has been published, a summary of the results will be published on the CancerHelp website (http://cancerhelp.cancerresearchuk.org/).
Intention to publish date
30/11/2018
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study will be stored in a publically available repository.
IPD sharing plan summary
Stored in publicly available repository
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2018 | Yes | No | |
| Results article | results | 01/12/2019 | 20/12/2019 | Yes | No |
| Plain English results | 25/10/2022 | No | Yes | ||
| Other publications | Post hoc analysis | 12/06/2024 | 13/06/2024 | Yes | No |