Trial record 2 of 91 for:    Open Studies | "Endometrial Neoplasms"

Robotic Versus Abdominal Surgery for Endometrial Cancer (RASHEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Henrik Falconer, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01847703
First received: May 2, 2013
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

This study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.


Condition Intervention
Endometrial Neoplasms
Procedure: Robotic surgery
Procedure: Abdominal surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Number of harvested lymph nodes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Extracted lymphatic tissue from 3 stations (above inferior mesenteric artery, below inferior mesenteric artery, pelvic) is analysed by a pathologist and the number of nodes for each station recorded and compared between the two groups


Secondary Outcome Measures:
  • Recurrence of cancer [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site

  • Lymphatic side-effects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Lymphatic side-effects will be monitored by repeated computed tomography (CT) 3 months and 12 months after surgery. Enrolled women will be asked specific, validated questions at follow-up

  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    All included participants will be asked to fill out a questionnaire (EORTC) to assess quality of life before and 1 year after surgery

  • Healthcare cost [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robotic surgery
Experimental method, to be compared with standard care
Procedure: Robotic surgery
Active Comparator: Abdominal surgery Procedure: Abdominal surgery
Current gold standard

Detailed Description:

Hypothesis: Robotic assisted laparoscopy (RAL)is equal in terms of oncologic and surgical safety as conventional abdominal surgery (AS) for high risk endometrial cancer (EC).

Methods: Women with high risk EC (defined as high grade endometrial, clear cell or serous) are randomized to either RAL or AS. Both groups will undergo complete surgical staging (hysterectomy, bilateral salpingoophorectomy, pelvic and paraaortal lymphadenectomy)

Primary endpoint: Number of harvested lymph nodes per station Secondary endpoints: Recurrences up to 3 year after surgery. Lymphatic side-effects, quality of life, cost, surgical morbidity.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-75 years of age
  • High risk endometrial cancer

Exclusion Criteria:

  • WHO performance>1
  • Severe comorbidity, ASA>3
  • Unable to understand information
  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: NCT01847703

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Henrik Falconer, MD, PhD    +46707742146    henrik.falconer@karolinska.se   
Principal Investigator: Henrik Falconer, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Henrik Falconer, MD, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Henrik Falconer, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01847703     History of Changes
Other Study ID Numbers: 2013/361-31/1
Study First Received: May 2, 2013
Last Updated: May 6, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 01, 2014