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
ClinicalTrials.gov (NCT)	NCT01086618
Clinical Trials Information System (CTIS)	2008-005911-16
Protocol serial number	UCL08/0079
Sponsor	University College London (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C32436/A10431)

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 of protocol

http://www.cancerhelp.org.uk/trials/a-trial-surgery-chemotherapy-advanced-bowel-cancer-isaac

Contact information

Mr Austin Obichere
Scientific

Department of Surgery
University College London Hospital
235 Euston Road
London
W1P 8BT
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre phase II randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	Overall survival Patients will be followed up every 3 months until death for survival and adverse events related to surgery or chemotherapy.
Key secondary outcome measure(s)	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.
Completion date	31/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	500
Key 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
Key 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
Date of first enrolment	01/06/2009
Date of final enrolment	29/07/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London Hospital

London
W1P 8BT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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