Colorectal cancer Cancer Malignant neoplasm of colon
Conditions
Interventions
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 we
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
Sponsors
NHS Greater Glasgow and Clyde
University of Glasgow
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Scotland, United Kingdom
Outcome results
None listed