Cancer of the EndometriumGOC2NCT01480999
Comparing Robotics and Laparoscopy With Laparotomy/Open Surgery for Endometrial Cancer
An observational study of Cancer of the Endometrium, run by University Health Network, Toronto at 7 sites in Canada.
Trial summary
The use of robotic surgery in the management of gynecologic cancers has increased exponentially in the United States since the implementation of technology in 2005. In Canada, access to the system is limited because of a lack of government funding. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer of the Endometrium
- How many people
- 550 participants
- Where
- 7 sitesCanada
- Study dates
- Nov 2011to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: New patients in the gynecologic oncology clinic will be offered the surgery that is deemed appropriate by their individual surgeon based on the patient's medical and surgical histories, type of malignancy, and the surgeon's expertise in open surgery, laparoscopy and/or robotic surgery.
Who may be able to join
- Any type of histologically confirmed early stage (stage 1 or 2) cancer of the endometrium
- ECOG Performance status of 0-1
- Suitable candidate for surgery
- Signed approved informed consent
- Female, 18 years of age or older
- Pre-operative health is graded as ASA I-III
- Patients able to complete baseline questions either on their own or with assistance
- Patient willing to comply with scheduled visits
Who cannot join
- Major abdominal surgery, chemotherapy or radiation within 3 months before the baseline visit
- Evidence of diffuse peritoneal carcinomatosis by imaging or clinical exam
- Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
- Patients who are breastfeeding or become pregnant during the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Kingston General Hospital
Kingston, Ontario, K7L5P9
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Prospective Study Evaluating Surgical and Quality of Life Outcomes in Robotics and Laparoscopy Compared to Laparotomy in Early Stage Endometrial Cancer
The use of robotic surgery in the management of gynecologic cancers has increased exponentially in the United States since the implementation of technology in 2005. In Canada, access to the system is limited because of a lack of government funding. The government has been reluctant to fund this technology because robust data, on the true impact to patient care, is lacking.
This project will prospectively examine outcomes of women, with early stage endometrial cancer, treated surgically. Open surgery will be compared to minimally invasive surgery (MIS) which will include conventional laparoscopy and robotic surgery. The data collected will include detailed assessment of surgical data, peri-operative events, quality of life analysis, health economic evaluation and evaluation of MIS rates.
- Conditions
- Cancer of the Endometrium
- Keywords
- Laparotomy, Open Surgery, Laparoscopy, Robotic surgery
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Laparotomy (open surgery) | Not described | |
| Laparoscopic surgery | Not described | |
| Robotic assisted surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Outcomes
Intraoperative complications as well as perioperative (time to discharge from hospital), early postoperative (<4 weeks) and long-term morbidity (4 weeks to 6 months)
Measured: 6 months
Quality of Life Outcomes
Validated quality of life questionnaires to assess the time it takes a patient to return to normal activity or work, the effect of surgery on their day-to-day living, pain, body image, sexuality, social life as well as about the costs associated with their surgery.
Measured: 6 months
Cost-effectiveness
Compare cost-effectiveness between MIS (minimally invasive surgery) and open surgery for early stage endometrial cancer, by evaluating lengths of hospital stay, in hospital costs and out of hospital costs
Measured: 6 months
Secondary outcomes (1)
Evolution of MIS rates
Determine the evolution of MIS rates at each centre participating in this study, including the number of surgeons offering MIS, and the number of patients offered MIS. Evaluate whether the introduction of robotic surgery increases the proportion of patients undergoing MIS. Compare the characteristics of patients undergoing robotic-assisted, laparoscopic or open surgery.
Measured: Prior to recruitment of the first patient and every 6 months for the duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2015
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the EndometriumStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcus Q Bernardini, MD MSc FRCSC, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480999
- Sponsor's protocol ID
- 11-0447-CE
- Acronym
- GOC2
- Status last verified
- Aug 2020
- First submitted
- 19 Oct 2011
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating Surgical and Quality of Life Outcomes in Robotics and Laparoscopy Compared to Laparotomy in Early Stage Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01480999
- Acronym / sponsor ID
- GOC2 / 11-0447-CE
- Conditions
- Cancer of the Endometrium
- Keywords
- Laparotomy, Open Surgery, Laparoscopy, Robotic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of robotic surgery in the management of gynecologic cancers has increased exponentially in the United States since the implementation of technology in 2005. In Canada, access to the system is limited because of a lack of government funding. The government has been reluctant to fund this technology because robust data, on the true impact to patient care, is lacking.
This project will prospectively examine outcomes of women, with early stage endometrial cancer, treated surgically. Open surgery will be compared to minimally invasive surgery (MIS) which will include conventional laparoscopy and robotic surgery. The data collected will include detailed assessment of surgical data, peri-operative events, quality of life analysis, health economic evaluation and evaluation of MIS rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laparotomy (open surgery) | – | – |
| Laparoscopic surgery | – | – |
| Robotic assisted surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New patients in the gynecologic oncology clinic will be offered the surgery that is deemed appropriate by their individual surgeon based on the patient's medical and surgical histories, type of malignancy, and the surgeon's expertise in open surgery, laparoscopy and/or robotic surgery.
Key inclusion criteria (8 listed)
- Any type of histologically confirmed early stage (stage 1 or 2) cancer of the endometrium
- ECOG Performance status of 0-1
- Suitable candidate for surgery
- Signed approved informed consent
- Female, 18 years of age or older
Key exclusion criteria (4 listed)
- Major abdominal surgery, chemotherapy or radiation within 3 months before the baseline visit
- Evidence of diffuse peritoneal carcinomatosis by imaging or clinical exam
- Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
- Patients who are breastfeeding or become pregnant during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical Outcomes
Time frame: 6 months
Intraoperative complications as well as perioperative (time to discharge from hospital), early postoperative (<4 weeks) and long-term morbidity (4 weeks to 6 months)
Quality of Life Outcomes
Time frame: 6 months
Validated quality of life questionnaires to assess the time it takes a patient to return to normal activity or work, the effect of surgery on their day-to-day living, pain, body image, sexuality, social life as well as about the costs associated with their surgery.
Cost-effectiveness
Time frame: 6 months
Compare cost-effectiveness between MIS (minimally invasive surgery) and open surgery for early stage endometrial cancer, by evaluating lengths of hospital stay, in hospital costs and out of hospital costs
1 secondary outcome
Evolution of MIS rates
Time frame: Prior to recruitment of the first patient and every 6 months for the duration of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Q Bernardini, MD MSc FRCSC principal investigator
Princess Margaret Hospital, Canada
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Endometrium, run by University Health Network, Toronto at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Outcomes (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.