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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 2016 by Uppsala University
Sponsor:
Collaborators:
Region Örebro County
University Hospital, Linkoeping
Lund University Hospital
Kalmar County Hospital
Skellefteå lasarett
Wroclaw Medical University
Sundsvall Hospital
Peking University First Hospital
Helsingborgs Hospital
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01975064
First received: October 28, 2013
Last updated: October 26, 2016
Last verified: October 2016
  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 Phase
Breast Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Drug: Propofol
Drug: Sevoflurane
Phase 4

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 2022
Estimated Primary Completion Date: December 2017 (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   (Adult, Senior)
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
China
Peking University First Teaching Hospital Recruiting
Beijing, China, 100034
Contact: Dong-Xin Wang, M.D., Ph.D.    008666551122    wangdongxin@hotmail.com   
Contact: Ran Li, M.D., Ph.D.    0086551122    liran@hotmail.com   
Poland
Wroclaw Medical University Recruiting
Wroclaw, Poland, 50-367
Contact: Waldemar Gozdzik, M.D., Ph.D.    0048717841001    waldemar.gozdzik@umed.wroc.pl   
Sweden
County Hospital Helsingborg Not yet recruiting
Helsingborg, Sweden, 25187
Contact: Per Flisberg, M.D., Ph.D.    0046424061000    per.flisberg@skane.se   
County Hospital, Kalmar Recruiting
Kalmar, Sweden, 39244
Contact: Andreas Ekman, M.D., Ph.D.    004648081000    andreas.ekman@ltkalmar.se   
Linköping University Hospital Recruiting
Linkoping, Sweden, 58185
Contact: Hans Bahlmann, M.D.    0046101030000    hans.bahlmann@regionostergotland.se   
Skane University Hospital, Lund Recruiting
Lund, Sweden, 22241
Contact: Johan Lundberg, M.D., Ph.D.    004646171000    johan.lundberg@med.lu.se   
Örebro University Hospital Recruiting
Orebro, Sweden, 70185
Contact: Rebecca Ahlgren, M.D., Ph.D.    0046196021000    rebecca.ahlgren@regionorebrolan.se   
Skellefteå Hospital Recruiting
Skelleftea, Sweden, 93141
Contact: Lars Hedlund, M.D., Ph.D.    0046910771000    lars.hedlund@vll.se   
County Hospital Sundsvall-Härnösand Recruiting
Sundsvall, Sweden, 85643
Contact: Jakob Walldén, M.D., Ph.D.    004660181000    jakob.wallden@lvn.se   
University Hospital, Uppsala Recruiting
Uppsala, Sweden, 75185
Contact: Fredrik Wärnberg, M.D., Ph.D.    0046186110000    fredrik.warnberg@akademiska.se   
Contact: Egidijus Semenas, M.D., Ph.D.    0046186110000    egidijus.semenas@akademiska.se   
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
Region Örebro County
University Hospital, Linkoeping
Lund University Hospital
Kalmar County Hospital
Skellefteå lasarett
Wroclaw Medical University
Sundsvall Hospital
Peking University First Hospital
Helsingborgs Hospital
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: October 26, 2016
Health Authority: Sweden: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on December 02, 2016