Cancer and Anesthesia: Survival After Radical Surgery - a Comparison Between Propofol or Sevoflurane Anesthesia (CAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Uppsala University
Sponsor:
Collaborators:
Umeå University
Karolinska Institutet
University Hospital Orebro
University Hospital, Linkoeping
Lund University
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01975064
First received: October 28, 2013
Last updated: December 6, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to determine whether anesthesia maintained with propofol results in better one- and five-year-survival than anesthesia maintained with sevoflurane.


Condition Intervention
Breast Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Drug: Propofol
Drug: Sevoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Randomized, Open-label Study to Compare Propofol Anesthesia With Sevoflurane Anesthesia in Terms of Overall Survival in Patients With Surgical Intervention for Either Breast-, Colon- or Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Over all survival [ Time Frame: Five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Over all survival [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 8000
Study Start Date: November 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol
Propofol for maintenance of anesthesia
Drug: Propofol
Propofol will be infused individually for a sufficient level of anesthesia during the entire surgical procedure.
Other Names:
  • Diprivan
  • Propofol-Lipuro
  • Propolipid
Active Comparator: Sevoflurane
Sevoflurane for maintenance of anesthesia
Drug: Sevoflurane
Sevoflurane will be administered by vaporizer individually for a sufficient level of anesthesia during the entire surgical procedure.
Other Names:
  • Sevoflurane Baxter
  • Sevorane inhalation vapour

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be informed of the nature of the study and have provided written informed consent
  • At least 18 years of age
  • Patient that is scheduled for elective radical breast- or colorectal cancer surgery in general anesthesia. 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).

Exclusion Criteria:

  • The surgery that is going to be made is an acute surgical procedure
  • The surgery that is going to be made is palliative surgery
  • Known or suspected hypersensitivity to either propofol or sevoflurane or presence of any contraindication according to the substances' valid summary of product characteristics.
  • Lack of suitability for participation in the trial, for any reason, as judged by the Investigator (e.g. communicative disturbances (language or intellectual)).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975064

Contacts
Contact: Mats Enlund, M.D., Ph.D. 004621173775 mats.enlund@ltv.se
Contact: Leif Bergkvist, M.D., Ph.D. 004621176371 leif.bergkvist@ltv.se

Locations
Sweden
Center for Clinical Research Recruiting
Vasteras, Sweden, SE-72189
Contact: Mats Enlund, M.D., Ph.D.    004621173775    mats.enlund@ltv.se   
Contact: Leif Bergkvist, M.D., Ph.D.    004621176371    leif.bergkvist@ltv.se   
Principal Investigator: Mats Enlund, M.D., Ph.D.         
Sub-Investigator: Leif Bergkvist, M.D., Ph.D.         
Sponsors and Collaborators
Uppsala University
Umeå University
Karolinska Institutet
University Hospital Orebro
University Hospital, Linkoeping
Lund University
Investigators
Principal Investigator: Mats Enlund, M.D., Ph.D. Uppsala university, Center of Clinical Research, Vasteras, Sweden
Study Chair: Leif Bergkvist, M.D., Ph.D. Uppsala university, Center of Clinical Research, Vasteras, Sweden
  More Information

Publications:

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01975064     History of Changes
Other Study ID Numbers: CAN/CKF-11115, 2013-002380-25
Study First Received: October 28, 2013
Last Updated: December 6, 2013
Health Authority: Sweden: Institutional Review Board

Keywords provided by Uppsala University:
Breast neoplasms
Colonic neoplasms
Rectal neoplasms

Additional relevant MeSH terms:
Colonic Neoplasms
Breast Neoplasms
Neoplasms
Rectal Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on August 19, 2014