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

Not Applicable

Completed

• Conditions: Colorectal cancer; Cancer; Malignant neoplasm of colon

• Registration Number: ISRCTN59757862
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29611518 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31852579 results (added 20/12/2019) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38865139/ Post hoc analysis (added 13/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-01
• Study Completion: 2017-11-30
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6088

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-inferiority question:<br>Disease free survival (defined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause).<br><br>Timing of randomisation question:<br>Projected probability of study completing recruitment with at most a 4-month overrun.