Status:
COMPLETED
Laparoscopic Approach to Cancer of the Endometrium
Lead Sponsor:
Queensland Centre for Gynaecological Cancer
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Tyco Healthcare Group
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive...
Detailed Description
This phase III international, multicenter, open-label, randomized clinical trial is an equivalence study with the hypothesis is that Total Laparoscopic Hysterectomy (TLH) is associated with equivalent...
Eligibility Criteria
Inclusion
- Patients who may be included for this study must have the following:
- Histologically confirmed primary endometrioid adenocarcinoma of the endometrium;
- Clinical stage I disease;
- ECOG Performance status of 0-1;
- Signed written informed consent;
- Females, aged 18 years or older.
Exclusion
- Patients will be excluded from participating from the study if they have any of the following:
- Other histologic type than endometrioid adenocarcinoma of the endometrium;
- Clinically advanced disease (stages II-IV);
- Uterine size larger than 10 weeks gestation;
- Estimated life expectancy of less than 6 months;
- Enlarged aortic lymph nodes;
- Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- Patient compliance and geographic proximity that does not allow adequate follow-up;
- Unfit to complete QoL measurements.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT00096408
Start Date
October 1 2005
End Date
December 1 2018
Last Update
March 20 2019
Active Locations (23)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
3
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia, 2305
4
Royal Hospital for Women
Randwick, New South Wales, Australia, 2031