Laparoscopic Approach to Cancer of the Endometrium

Queensland Centre for Gynaecological Cancer760 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

760

Conditions

Endometrial Cancer

Interventions

Total Abdominal HysterectomyPROCEDURE

For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.

Total Laparoscopic HysterectomyPROCEDURE

The technique of total laparoscopic hysterectomy (TLH), utilising the McCartney tube, has been developed by Anthony J. McCartney over the last 10 years. It allows the completion of the hysterectomy entirely laparoscopically, without the need for additional vaginal surgery.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Outcomes

Primary Outcomes

Disease free survival

Time frame: 4.5 years from surgery

Secondary Outcomes

Intra/Peri/Post-operative and long-term morbidity

Time frame: 30 days from surgery

Patterns of recurrence

Time frame: 4.5 years from surgery

Pain and analgesia

Time frame: 1 week, 1 month, 3 months and 6 months postoperative.

Quality of Life

Time frame: Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.