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

Phase 1

• Conditions: Colorectal Cancer; MedDRA version: 14.1 Level: PT Classification code 10010034 Term: Colorectal cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: PT Classification code 10010033 Term: Colorectal cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-003957-10-SE
• Lead Sponsor: Gastrointestinal Onkologisk Förening

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-06
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 9500

Inclusion Criteria

Fully resected stage III colorectal cancer or High risk stage II disease (defined as T4 disease, tumour perforation, obstruction, inadequate nodal harvest as indicated by <10 nodes examined, poorly differentiated histology or extramural venous/lymphatic invasion) See tumour staging guideline in Appendix 11 for clarification on SCOT eligibility;No evidence of residual or metastatic disease;
Within 10 weeks of surgery at time of randomisation;
WHO PS= 0 or 1; aged > or = 18 years; life expectancy of greater than 5 years;
CEA within normal limits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior chemotherapy
Prior abdomino-pelvic radiotherapy;
Moderate/severe renal impairment (GFR <30ml/min);
ANC<1.5 X10^9/L; Platelets <100 X 10^9/L;Hgb<9 g/dl;
AST/ALT > 2.5 x ULN;
Clinically significant cardiovascular disease;
Pregnant or lactating women, or women of child bearing potential not using adequate contraception;
Prior malignancy( other than adequately treated carcinoma in situ of the uterine cervix or squamous cell carcinoma of the skin), unless the disease free interval has been at least 5 years;
Known dihydropyrimidine dehydrogenase deficiency (DPD).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study aims to ascertain whether 3 months of treatment for colorectal cancer is as efficacious as 6 months with the further aim of providing robust evidence on the cost effictiveness of reducing the duration of adjuvant therapy.;Secondary Objective: Economic analysis to assess the 2 treatment alternatives; comparison of 2 randomisation methodologies;Primary end point(s): Disease free survival (defined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause)