SCOT - Short Course Oncology Therapy: a study of adjuvant chemotherapy in colorectal cancer

ISRCTN	ISRCTN59757862
DOI	https://doi.org/10.1186/ISRCTN59757862
EudraCT/CTIS number	2007-003957-10
ClinicalTrials.gov number	NCT00749450
Secondary identifying numbers	SCOT 2007-01

Submission date: 10/07/2007
Registration date: 01/08/2007
Last edited: 13/06/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-to-find-out-how-long-to-give-chemotherapy-after-surgery-for-bowel-cancer

Contact information

Dr Tim Iveson
Scientific

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

Study information

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
Participant information sheet	Participating information sheet no longer available
Scientific title	SCOT - Short Course Oncology Therapy: a study of adjuvant chemotherapy in colorectal cancer by the CACTUS and QUASAR 3 Groups
Study 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
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

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	6144
Total final enrolment	6088
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 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

NHS Greater Glasgow and Clyde
Government

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

Website	http://www.nhsggc.org.uk/r&d
"ROR"	https://ror.org/05kdz4d87

University of Glasgow
University/education

University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom

Website	http://www.gla.ac.uk/
"ROR"	https://ror.org/00vtgdb53

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0601705)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date	30/11/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
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/).
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a publically 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

Editorial Notes

13/06/2024: Publication reference added.
25/10/2022: Cancer Research UK plain English results link added.
20/12/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
04/04/2018: Publication reference added.
12/10/2017: Recruitment start date changed from 27/03/2008 to 09/05/2008.
27/07/2017: Overall trial start date changed from 27/03/2008 to 01/08/2005 (as an estimate of when initial planning started). Overall trial end date changed from 31/05/2017 to 30/11/2017. Added intention to publish date.
19/07/2017: Study status verified with the principal investigator. Overall trial end date changed from 30/11/2014 to 31/05/2017. Added publication and dissemination plan and data sharing plan.
07/06/2017: No publications found in PubMed, verifying study status with principal investigator.
22/02/2011: The overall trial end date for this trial was updated from 01/04/2012 to 27/03/2013.
10/07/2014: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/11/2014 to 30/11/2014.
2. The target number of participants was changed from 9500 to 6144.
Please note that the overall trial start date has been updated from 31/03/2008 to 27/03/2008.