A randomized study to evaluate whether there is a difference in survival between two different forms of anaesthesia. The study will evaluate patients that are scheduled for a surgery for either breast-, colon- or rectalcancer.
- Conditions
- Patients with breast- or colorectal cancer that will undergo radical surgery for this cancer. During the surgery general aneasthesia with either propofol or sevoflurane will be used.MedDRA version: 20.0Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-002380-25-HR
- Lead Sponsor
- CKF at Västmanlands hospital Västerås
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 8000
1.Be informed of the nature of the study and have provided written informed consent
2.At least 18 years of age
3.Patient that is scheduled for elective radical breast- or colorectal cancer surgery in general anaesthesia. Radical surgery means that the aim of the surgery is to cure (adjuvant treatment such as chemotherapy and/or radiation therapy seen as part of the curative treatment)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5000
1. The surgery that is going to be made is an emergancy surgical procedure
2. The surgery that is going to be made is palliative surgery
3. Known or suspected hypersensitivity to either propofol or sevoflurane or presence of any contraindication according to the substances’ valid SPC.
4. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator (e.g. communicative disturbances (language or intellectual))
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate whether the one- and five-year survival after radical breast-, or colorectal cancer surgery in general anaesthesia is significantly higher in patients given the intravenously administered hypnotic propofol than in patients given the inhalational hypnotic sevoflurane.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint will be a comparison of overall survival using time to event (i.e. death) analysis. ;Timepoint(s) of evaluation of this end point: One year and five year after radical surgery
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable