ISAAC: a randomised trial for patients with asymptomatic advanced colorectal cancer to look at the benefits of undergoing surgical removal of their primary tumour before receiving chemotherapy for metastatic disease
| ISRCTN | ISRCTN10963271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10963271 |
| EudraCT/CTIS number | 2008-005911-16 |
| ClinicalTrials.gov number | NCT01086618 |
| Secondary identifying numbers | UCL08/0079 |
- Submission date
- 31/10/2008
- Registration date
- 21/11/2008
- Last edited
- 19/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
http://www.cancerhelp.org.uk/trials/a-trial-surgery-chemotherapy-advanced-bowel-cancer-isaac
Contact information
Mr Austin Obichere
Scientific
Scientific
Department of Surgery
University College London Hospital
235 Euston Road
London
W1P 8BT
United Kingdom
Study information
| Study design | Multicentre phase II randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | ISAAC: a randomised trial of Initial Surgery in Advanced Asymptomatic Colorectal cancer patients receiving chemotherapy for metastatic disease |
| Study acronym | ISAAC |
| Study hypothesis | The ISAAC trial aims to investigate whether survival is improved by resection of the asymptomatic primary tumour prior to chemotherapy compared to chemotherapy alone in patients with advanced colorectal cancer. |
| Ethics approval(s) | South East Research Ethics Committee, 15/07/2009, ref: 09/H1102/60 |
| Condition | Colorectal cancer |
| Intervention | 1. Resection of the asymptomatic primary tumour prior to chemotherapy 2. Chemotherapy alone There is no prescribed treatment in this trial. The chemotherapy regimen is at the discretion of each treating clinician who may choose the standard treatment for that hospital or the patient can be entered into a chemotherapy treatment trial. The surgical treatment is at the discretion of the treating surgeon. |
| Intervention type | Mixed |
| Primary outcome measure | Overall survival Patients will be followed up every 3 months until death for survival and adverse events related to surgery or chemotherapy. |
| Secondary outcome measures | 1. Morbidity of chemotherapy and surgery 2. Quality of life, assessed at 3 months and 6 months only 3. Economic evaluation Patients will be followed up every 3 months until death for survival and adverse events related to surgery or chemotherapy. |
| Overall study start date | 01/06/2009 |
| Overall study end date | 31/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Participant inclusion criteria | 1. Histologically or cytologically proven colorectal cancer 2. Metastases which are unresectable at presentation in the opinion of the appropriate multi-disciplinary team (MDT) 3. Primary tumour that in the MDT's opinion does not require immediate or emergency surgery or intervention 4. Patients who are referred for prophylactic colonic stents are eligible 5. Patient considered fit for systemic chemotherapy and surgery as determined by the local colorectal cancer MDT 6. Adequate full blood count (haemoglobin [Hb] greater than 10.0 g/dl; white blood cell count [WBC] greater than 3.0 x 10^9/L; platelets [Plts] greater than 100 x 10^9/L) 7. Adequate renal biochemistry: calculated glomerular filtration rate (GFR) greater than 50 ml/min using the Wright formula or measured by ethylenediaminetetraacetic acid (EDTA) clearance 8. Adequate hepatobiliary function: bilirubin less than 25 mmol/l 9. World Health Organization (WHO) performance status of 0 or 1 10. If female and of childbearing potential, must have a negative pregnancy test prior to trial entry and agree to avoid pregnancy during the trial 11. Patients over 18 years of age (either sex) able and willing to provide written informed consent for the trial and able to comply with treatment and follow-up schedule |
| Participant exclusion criteria | 1. Serious co-morbidity precluding systemic chemotherapy 2. Unresectable primary tumour 3. Unequivocal extensive peritoneal metastases 4. History of malignant disease in the preceding five years with the exception of non-melanomatous skin cancer and in situ cervical cancer 5. Serious medical co-morbidity, e.g. uncontrolled inflammatory bowel disease, uncontrolled angina or recent (less than six months) myocardial infarction, another serious medical condition judged to compromise ability to tolerate chemotherapy and/or surgery 6. Less than 18 years of age 7. Pregnant or breast feeding |
| Recruitment start date | 01/06/2009 |
| Recruitment end date | 29/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London Hospital
London
W1P 8BT
United Kingdom
W1P 8BT
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| Website | http://www.ctc.ucl.ac.uk |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C32436/A10431)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/03/2020: EudraCT number added.
10/05/2019: No publications found. Verifying results with principal investigator.
07/06/2017: No publications found in PubMed, verifying study status with principal investigator.
12/12/2011: The overall trial end date was changed from 31/05/2013 to 31/07/2013.
11/02/2009: This record was updated to include amended trial dates. The initial trial dates at the time of registration were:
Initial overall trial start date: 01/03/2009
Initial overall trial end date: 28/02/2013
