Laparoscopic Approach to Cancer of the Endometrium

Phase 3

Completed

• Conditions: Endometrial Cancer

• Registration Number: NCT00096408
• Lead Sponsor: Queensland Centre for Gynaecological Cancer

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 Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).

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 disease-free survival when compared to the standard treatment of Total Abdominal Hysterectomy (TAH) for women with apparent Stage I endometrial cancer.

The secondary hypotheses are:

* TLH is associated with equivalent or improved Quality of Life (QoL) at 6 months;

* TLH is associated with reduced treatment-related morbidity;

* TLH is associated with shorter hospital stay;

* TLH is associated with less analgesic consumption;

* TLH is cost effective;

* TLH is associated with improved pelvic floor function.

Study Timeline

• Study First Submitted QC: 2004-11-08
• Study First Submitted: 2004-11-09
• Study First Posted: 2004-11-09
• Study Start: 2005-10
• Primary Completion: 2016-04
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 760

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;
• Females, aged 18 years or older.

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: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease free survival	4.5 years from surgery

Secondary Outcome Measures

Name	Time	Method
Intra/Peri/Post-operative and long-term morbidity	30 days from surgery
Quality of Life	Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively.
Pain and analgesia	1 week, 1 month, 3 months and 6 months postoperative.
Patterns of recurrence	4.5 years from surgery

Trial Locations

Locations (23)

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Newcastle Private Hospital; 🇦🇺 New Lambton Heights, New South Wales, Australia

John Hunter Hospital; 🇦🇺 New Lambton, New South Wales, Australia

Royal Hospital for Women; 🇦🇺 Randwick, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

The Wesley Hospital; 🇦🇺 Auchenflower, Queensland, Australia

Greenslopes Private Hospital; 🇦🇺 Greenslopes, Queensland, Australia

Royal Brisbane and Women's Hospital; 🇦🇺 Herston, Queensland, Australia

Mater Adult Public Hospital; 🇦🇺 South Brisbane, Queensland, Australia

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