EUCTR2013-002380-25-HR
Active, not recruiting
Phase 1
A Randomized, Open-label Study to compare Propofol Anaesthesia with Sevoflurane Anaesthesia in terms of Overall Survival in Patients with Surgical Intervention for either Breast-, Colon- or Rectalcancer
CKF at Västmanlands hospital Västerås0 sites8,000 target enrollmentFebruary 25, 2020
ConditionsPatients 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 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)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 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- CKF at Västmanlands hospital Västerås
- Enrollment
- 8000
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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))
Outcomes
Primary Outcomes
Not specified
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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.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: 14.1Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: 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]EUCTR2013-002380-25-SECKF at Västmanlands hospital Västerås
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