|
Welcome
|
|
06 January 2009
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| SCOT - Short Course Oncology Therapy: a study of adjuvant chemotherapy in colorectal cancer by the CACTUS and QUASAR 3 Groups |
| ISRCTN | ISRCTN59757862 |
| ClinicalTrials.gov identifier | NCT00749450 |
| Public title | SCOT - Short Course Oncology Therapy: a study of adjuvant chemotherapy in colorectal cancer by the CACTUS and QUASAR 3 Groups |
| Scientific title | |
| Acronym | SCOT - Short Course Oncology Therapy |
| Serial number at source | SCOT 2007-01 |
| Study hypothesis | The study aims to ascertain whether three months of treatment is as efficacious as six months with the further aim of providing robust evidence on the cost-effectiveness of reducing the duration of adjuvant therapy. |
| Ethics approval |
Ethics approval received from the West Glasgow Ethics Committee 1 on the 21st January 2008 (ref: 07/S08703/136). Site Specific approval (SSI) must be obtained for all participating centres.
The study will be carried out in agreement with "Declaration of Helsinki" amended in Tokyo, Venice, Hong Kong, Edinburgh with revisions in Washington (2002) and Tokyo (2004). |
| Study design | Open randomised controlled multi-centre non-inferiority trial incorporating a nested methodology study and an initial pilot period. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Colorectal cancer |
| Participants - 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 |
| Participants - 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 child bearing potential not using adequate contraception 10. Previous malignancy 11. Known Dihydropyrimidine Dehydrogenase (DPD) deficiency In addition, for the three-month randomisation point, only patients deemed to be fit to continue treatment will be randomised. |
| Anticipated start date | 27/03/2008 |
| Anticipated end date | 01/04/2012 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 9,500 |
| Interventions |
Please note that the above anticipated start date has been updated. The previous anticipated start date was 31/03/2008.
Interventions: Control arm - six months of XELOX/FOLFOX chemotherapy Experimental arm - three months of XELOX/FOLFOX chemotherapy The treatment regimen will be either: 1. Oxaliplatin/Capecitabine (XELOX), which is a three weekly cycle OR; 2. Oxaliplatin/5-Fluorouracil (5 FU) (FOLFOX), which is a two 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 three weekly intervals or if receiving FOLFOX regimen on control arm would receive 12 cycles at two weekly intervals. The same would apply for the experimental arm, for example a patient receiving XELOX regimen would receive 4 cycles at three weekly intervals or if receiving FOLFOX regimen 6 cycles at two weekly intervals. XELOX regimen dosage details: three weeks (21 day cycle) oxaliplatin 130 mg/m^2 intravenous (IV) over two hours on day one, capecitabine 1000 mg/m^2 on day 1 to day 14, twice daily (bid) (oral). FOLFOX regimen dosage details: two weeks (14 day cycle) oxaliplatin 85 mg/m^2 IV over two hours on day one, 5 FU 400 mg/m^2 on day one bolus injection, 5 FU 600 mg/m^2 on day two IV over 22 hours, 5 FU 400 mg/m^2 on day three bolus injection, 5 FU 600 mg/m^2 day three IV over 22 hours. Clinical follow-up once treatment is complete will be monthly for three months (experimental arm only), three monthly until month 12 (end of year one), six-monthly until month 24 (end of year two), then annually thereafter. The maximum duration of follow-up will be seven years. |
| Primary outcome measure(s) |
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 four-month overrun. |
| Secondary outcome measure(s) |
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 three-monthly intervals until month 12 (end of year one) then six-monthly until month 24 (end of year two). Computed Tomography (CT) scanning will be performed at six-monthly intervals for two 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 (three-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. |
| Sources of funding | Medical Research Council (MRC) (UK) (ref: G0601705) |
| Trial website | |
| Publications | |
| Contact name | Prof Jim Cassidy |
| Address |
The Beatson West of Scotland Cancer Centre
Level 4 1053 Great Western Road |
| City/town | Glasgow |
| Zip/Postcode | G12 0YN |
| Country | United Kingdom |
| Sponsor | Greater Glasgow and Clyde Health Board/Glasgow University (UK) |
| Address |
NHS North Glasgow University Hospitals Division
West R&D Office, Administration Building Ground Floor, Room 9 Western Infirmary |
| City/town | Glasgow |
| Zip/Postcode | G11 6NT |
| Country | United Kingdom |
| Sponsor website: | http://www.nhsgg.org.uk/content/ |
| Date applied | 10/07/2007 |
| Last edited | 01/12/2008 |
| Date ISRCTN assigned | 01/08/2007 |
|
|
|
| © ISRCTN | |
|
|
|
|