Condition category
Cancer
Date applied
31/10/2008
Date assigned
21/11/2008
Last edited
05/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Austin Obichere

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01086618

Protocol/serial number

UCL08/0079

Study information

Scientific title

ISAAC: a randomised trial of Initial Surgery in Advanced Asymptomatic Colorectal cancer patients receiving chemotherapy for metastatic disease

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.

On 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

On 12/12/2011 the overall trial end date was changed from 31/05/2013 to 31/07/2013.

Ethics approval

South East Research Ethics Committee, 15/07/2009, ref: 09/H1102/60

Study design

Multicentre phase II randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2009

Overall trial end date

31/07/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

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

United Kingdom

Trial participating centre

University College London Hospital
London
W1P 8BT
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

http://www.ctc.ucl.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C32436/A10431)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes