ACE – Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial

Phase 3

Recruiting

• Conditions: Endometrial Adenocarcinoma - FIGO Stage 1; Cancer - Womb (Uterine or endometrial cancer)

• Registration Number: ACTRN12606000261516
• Lead Sponsor: Qld Centre for Gynaecological Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 755

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified