Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000662268
Ethics application status
Approved
Date submitted
30/07/2009
Date registered
5/08/2009
Date last updated
18/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Short Course Oncology Therapy. A study of adjuvant chemotherapy in colorectal cancer.
Scientific title
Short Course Oncology Therapy(SCOT). A study of post operative chemotherapy for 12 weeks versus 24 weeks with oxaliplatin/Fluorouracil (5FU) to establish disease free survival outcomes in locally advanced colon cancer.
Secondary ID [1] 253226 0
Nil
Universal Trial Number (UTN)
Trial acronym
SCOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon Cancer 4372 0
Condition category
Condition code
Cancer 4617 4617 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sites are able to select either oxaliplatin/5-FU (Folfox) or oxaliplatin/capecitabine (Xelox).
Folfox - Oxaliplatin 85mg/m2 IV (intravenously) on day 1 concurrently with L-folinic acid 175mg or folinic acid 350mg(Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours), followed by 5-fluorouracil 400mg/m2 IV bolus injection over 5 minutes followed by 5-flourouracil 2400mg/m2 IV continuous infusion over 46 hours in 14 day cycle for 12 weeks. Treatment with combination Oxaliplatin -5 Fluorouracil (5-FU) is on days 1-3 and rest days are day 4-14. Use of L-folinic acid 175mg or folinic acid 250mg is determined by the pharmacy stock and usual practice at site.
Xelox – Oxaliplatin 130mg/m2 IV on day 1 (Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours). Capecitabine 1000mg/m2 PO twice daily for 14 days for 12 weeks.
Intervention code [1] 4104 0
Treatment: Drugs
Comparator / control treatment
Sites are able to select either oxaliplatin/5-FU (Folfox) or oxaliplatin/capecitabine (Xelox).
Folfox - Oxaliplatin 85mg/m2 IV (intravenously) on day 1 concurrently with L-folinic acid 175mg or folinic acid 350mg(Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours), followed by 5-fluorouracil 400mg/m2 IV bolus injection over 5 minutes followed by 5-flourouracil 2400mg/m2 IV continuous infusion over 46 hours in 14 day cycle for 24 weeks. Treatment with combination Oxaliplatin -5 Fluorouracil (5-FU) is on days 1-3 and rest days are day 4-14. Use of L-folinic acid 175mg or folinic acid 250mg is determined by the pharmacy stock and usual practice at site.
Xelox – Oxaliplatin 130mg/m2 IV on day 1 (Oxaliplatin should be given in 250-500ml of 5% glucose (max1gm/ml) over 2 hours). Capecitabine 1000mg/m2 PO twice daily for 14 days for 24 weeks
.
Control group
Active

Outcomes
Primary outcome [1] 5490 0
Disease free survival, determined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause.
Timepoint [1] 5490 0
During treatment: prior to each treatment cycle. Patients on the 3 month treatment arm will be reviewed 4 weekly for the first twelve weeks after completion of chemotherapy. Clinical examination and Carcinoembryonic Antigen test will be performed at each visit. Follow-up: assessment will be at three monthly intervals until month 12 then 6 monthly until month 24 and annually thereafter.
Secondary outcome [1] 9245 0
Overall survival.
Timepoint [1] 9245 0
Every 3 months until end of year 1 then 6 monthly until end of year 2 and yearly after that for seven years from date of first patient randomised into study.
Secondary outcome [2] 9246 0
Toxicity, assessed through physical examination and patient reports.
Timepoint [2] 9246 0
Arm A = 24 weeks of treatment patients will be assessed for toxicity at each visit during treament period and at 4 weeks post treatment. Arm B = 12 weeks of treament patients will be assessed for toxicity at each visit during treament, 4 weeks post treatment and monthly up to end of month 6 post randomisation.
Secondary outcome [3] 9247 0
Quality of life
assessed by completion of Quality of Life Questionnaires
Timepoint [3] 9247 0
Prior to randomisation, prior to each treamtent cycle, monthly for 3 months after 12 weeks of treatment in Arm-B and both arms at 9 and 12 months on study,

Eligibility
Key inclusion criteria
1. Male or female patients with fully resected stage III colon cancer
2. No evidence of residual or metastatic disease.
3. Patients must be randomised within 10 weeks of surgery.
4. World Health Organisation(WHO) Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1
5. Life expectancy >5 years with reference to non-cancer related diseases.
6 Written informed consent
7. Carcinoembryonic Antigen (CEA) within normal limits
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous chemotherapy.
2. previous abdomino-pelvic radiotherapy. 3. moderate/severe renal impairment, Glomerular Filtration Rate (GFR<30 ml/min) as calculated by the Cockcroft and Gault equation.
4. absolute neutrophil count <1.5x109/L
5. Platelet count <100x10 9/L
6. Haemoglobin <9g/dL
7. Aspartate aminotransferase/alanine aminotransferase > 2.5 x upper limit of normal.
8. Clinically significant cardiovascular disease. (i.e. active; or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension.)
9. Pregnancy/lactation or of child bearing potential and not using medically approved contraception.
10. previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease free interval of at least 5 years.
11. known or suspected dihydropyrimidine dehydrogenase deficiency (DPD)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
all patients entering this study will be randomised to receive either 12 weeks or 24 weeks of treatment. Randomisation will be via a central randomisation telephone/fax number directly to the Clinical Trial Centre where randomisation will take place via access to a central trial computer for allocation to Arm A or Arm B.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A minimisation algorithm incorporating a random component will be used to allocate patients to treatment arms; the factors used in th minimisation will be centre, choice of regiment, gender, N-stage and T-stage of disease.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2010
Actual
20/04/2010
Date of last participant enrolment
Anticipated
Actual
29/11/2013
Date of last data collection
Anticipated
Actual
28/10/2016
Sample size
Target
213
Accrual to date
Final
213
Recruitment in Australia
Recruitment state(s)
NSW,VIC,ACT,QLD,SA,WA,NT,TAS
Recruitment outside Australia
Country [1] 1597 0
New Zealand
State/province [1] 1597 0

Funding & Sponsors
Funding source category [1] 4553 0
Government body
Name [1] 4553 0
Cancer Australia
Country [1] 4553 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastrointestinal Trials Group (AGITG)
Address
NHMRC Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 4109 0
Other Collaborative groups
Name [1] 4109 0
Cancer Clinical Trials Unit Scotland (CaCTUS)
Address [1] 4109 0
Cancer Research UK Clinical Trials Office LevelO Beatson West of Scotland Cancer Centre 1053 Great Western Rd Glasgow G12 OYN
Country [1] 4109 0
United Kingdom
Other collaborator category [1] 582 0
Other Collaborative groups
Name [1] 582 0
Oncology Clinical Trials Office (OCTO)
Address [1] 582 0
University of Oxford Oncology Clinical Trials Office Department of Clinical Pharmacology Radcliffe Infirmary Woodstock Rd Oxford OX2 6YD
Country [1] 582 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6603 0
Cancer Institute NSW Research Ethics Committee
Ethics committee address [1] 6603 0
Ethics committee country [1] 6603 0
Australia
Date submitted for ethics approval [1] 6603 0
28/05/2009
Approval date [1] 6603 0
25/08/2009
Ethics approval number [1] 6603 0
2009C/06/098
Ethics committee name [2] 291299 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [2] 291299 0
Ethics committee country [2] 291299 0
Australia
Date submitted for ethics approval [2] 291299 0
Approval date [2] 291299 0
18/11/2013
Ethics approval number [2] 291299 0
X13-0169

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29315 0
Dr Andrew Haydon
Address 29315 0
Dr Andrew Haydon
NHMRC Clinical Trials Centre
Locked bag 77, Camperdown, NSW, 1450
Country 29315 0
Australia
Phone 29315 0
61 2 95625000
Fax 29315 0
Email 29315 0
[email protected]
Contact person for public queries
Name 12562 0
SCOT Trial Coordinator
Address 12562 0
SCOT Trial Coordinator
NHMRC Clinical Trials Centre
Locked Bag 77 Camperdown NSW 1450
Country 12562 0
Australia
Phone 12562 0
61 2 95625000
Fax 12562 0
61 2 9562 5094
Email 12562 0
[email protected]
Contact person for scientific queries
Name 3490 0
SCOT Trial Coordinator
Address 3490 0
SCOT Trial Coordinator
NHMRC Clinical Trials Centre
Locked Bag 77 Camperdown NSW 1450
Country 3490 0
Australia
Phone 3490 0
61 2 9562 5000
Fax 3490 0
61 2 9562 5094
Email 3490 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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