Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

this group will benefit from standard care including: one surgical consultation, one anesthesia consultation, surgery followed by 2-4 days of hospitalization and most of the time 3 post-operative consultations (M1, M6, M12) during the first operative year

Preoperative and postoperative protocols will be applied for optimizing same-day discharge. Gynaecologists, anaesthetists, and nursing staff will work as a team. A specific anesthesia consultation will focus on ambulatory surgery management. A geriatric evaluation will be offered to women over 70 years old with a score ≤14 according to G8 screening tool. A dietetic evaluation will be offered to women with BMI ≥ 35. A nursing consultation will be offered, as patient and their family preparation prior to ambulatory surgery is important.

total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy

ambulatory surgery

standard surgery

Geoffroy CANLORBE, MD

Lise ROCHAIX, MD PHD

To date, cost-utility, safety, and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low- and intermediate-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

In developed countries, endometrial cancer is the fourth most common cancer in women. Women with stage I disease, representing almost 75% of cases, have an overall survival of 95%. According to the European guidelines, the standard surgical approach for stage I endometrial cancer consists of laparoscopic total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy. For patients undergoing laparoscopic surgery for gynecological malignancies, most studies report average hospital stays of 1 day after surgery. Patients are commonly kept in the hospital following surgery for pain and nausea control, prolonged bladder catheterization, and observation for surgical complications. However, some recent retrospective studies show that same-day discharge for patients undergoing laparoscopic staging for endometrial cancer is feasible and safe, despite associated comorbidities (i.e., obesity, hypertension, diabetes) related to endometrial cancer.

A short hospital stay decreases the risk of exposure to hospital infections, causes less disruption to the patient's personal life, results in potential cost savings for patients and relatives, as well as for hospitals, and there is positive feedback regarding the social environment of patients as they return rapidly to daily activities and work.

To date, safety, feasibility and cost-utility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low, intermediate- and high-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

Preoperative and postoperative protocols (including geriatric and dietetic evaluation, and anesthesia and nursing consultation) will be applied for optimizing same-day discharge of patients randomly assigned to ambulatory surgery.

Data will be collected in conjunction with usual care visit, 1 month after initial surgery.

The economic evaluation will closely follow the 2011 French National Authority for Health (HAS) economic evaluation guidelines and the evaluation proposal will have three complementary parts with a full cooperation between those involved in the evaluation:

First, the economic evaluation will focus on evaluating the cost-utility profile of ambulatory surgery in endometrial cancer in France. This economic evaluation will include a micro-costing study to estimate by direct observation the cost of resources used during the ambulatory pathway, and the total cost of patients' care in each group. The primary endpoint will be the incremental cost-utility ratio using the 30-day health related quality of life. It will be calculated for both groups using health-related quality of life (HRQoL) scores from the EQ-5D and converted to utility scores using French weights. QALYs will be computed at 30 days (primary analysis) using both mortality and HRQoL scores.

Second, the investigators will perform an analysis of patients' and professionals' preferences about ambulatory care pathways. These preferences will be analyzed in depth, using both surveys and recent tools developed in experimental economics. Health care professionals' views and preferences will be collected, using questionnaires and face-to-face interviews both at the beginning of the study (M0). Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics.

Third, a thorough analysis of the ethical and inequality aspects tied to the development of ambulatory surgery in endometrial cancer will be developed, following the methodological guidance issued in 2013 by the HAS. Special emphasis will be laid on equity issues in the measurement of patients' benefits, using a capability approach (ICECAP-A questionnaire).

Finally, another secondary objective will be to assess the safety and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer, and to validate biomarkers of high risk of nodal involvement in a translational study (complementary budget will be asked for this part).

a multicentre, prospective and randomised study

Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)

Cost-utility, Safety and Feasibility of Ambulatory Surgery Versus Traditional Pathway in the Management of Endometrial Cancer: a Multicentre, Prospective and Randomised Study

It will be calculated for both groups using health-related quality of life (HRQoL) scores from the EQ-5D and converted to utility scores using French weights

QALYs will be computed using both mortality and HRQoL scores

Rate of women requiring overnight admission

Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics.

Ecole d'econmie de Paris (PSE)-Hospinnomics

Université Montpellier

Université de Rennes 1 CREM CNRS UMR 6211

Assistance Publique - Hôpitaux de Paris

Adenocarcinoma

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Determination of the integrated genomic-pathologic profile to determine adjuvant treatment: observation for POLE-mutated profile; vaginal brachytherapy for intermediate profile; chemo-radiotherapy for p53-abnormal profile.

Adjuvant vaginal brachytherapy for intermediate risk (stage I A with G3 or stage I B with G1-2) and external beam pelvic radiotherapy for high-intermediate risk (stage I B with G3, or stage II) (standard treatment)

Internal radiation of the vaginal vault using a vaginal cylinder. For brachytherapy administered alone it is recommended: suggested dose is either 3 fractions of 7 Gy or 5 fractions of 6 Gy.

For brachytherapy administered after completion of External beam radiotherapy (EBRT):

Total dose should aim to be 65 Gy, and suggested dose is 2-3 fractions of 5-6 Gy

Vaginal brachytherapy

External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions

External beam radiotherapy

No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment

Observation

4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )

Chemoradiation therapy

Xinyu Wang, MD

Yang Li, PhD

Gang Chen

Ding Ma

Jie Jiang

Beihua Kong

Yang Li

Zhiqi Wang

Yu Zhang, MD

Yanling Feng

Jihong Liu

Yutao Guan

Lingjun Zhao

Xiaojun Chen

Xiaoping Wan

This is a prospective, multicenter, randomized phase III trial among women with endometrioid adenocarcinoma with high-intermediate and intermediate risk features to investigate the role of integrated genomic-pathologic classification to determine if participants should receive no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy or chemo-radiation therapy based on molecular features as compared to standard radiation therapy.

Adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinically relevant reduction of the risk of relapse by the adjuvant treatment. Risk profiles have traditionally been based on clinicopathological factors such as age, stage, grade, Lymph-Vascular Space Invasion (LVSI) and depth of invasion. Newer, both molecular-genetic (the cancer genome atlas subgroups) have become available which are strongly related to outcomes and risk of cancer spread. Based on 2022 National Comprehensive Cancer Network (NCCN) guideline and the ongoing "Portec-4a" trial, this randomized trial using integrated genomic-pathologic classification to assign adjuvant treatment for women with stage I-II high-intermediate and intermediate risk endometrioid adenocarcinoma.

PROfiling Based Endometrial Cancer Adjuvant Therapy

Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma

Vaginal, pelvic and distant relapse split by risk profile and compared between the 2 arms

Vaginal, pelvic or distant recurrence as first failure

Relapse-free survival (survival without relapse)

Treatment-related symptoms according to CTCAE v 5.0

Quality of Life Core Questionnaire (QLQC-30) - clinically relevant changes on Quality of Life Core Questionnaire-30 functioning scales, general quality of life and general cancer symptoms, quite a bit/very much vs no or mild symptoms

All hospital based health care costs used with primary treatment or during followup for treatment of adverse events and/or treatment for relapse

Tongji Hospital

Qilu Hospital of Shandong University

Obstetrics & Gynecology Hospital of Fudan University

Sun Yat-sen University

Peking University People's Hospital

Shanghai First Maternity and Infant Hospital

Xiangya Hospital of Central South University

Anhui Provincial Cancer Hospital

Ningbo Women & Children's Hospital

Ningbo No. 1 Hospital

Women's Hospital School Of Medicine Zhejiang University

Clinical Professor

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Neoplasms

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Ovarian Cancer

This arm includes patients with endometrioid adenocarcinoma of the endometrium of low- and intermediate-risk who will undergo a laparoscopic total hysterectomy and bilateral salpingo-oophorectomy with sentinel lymph node biopsy (SLNB) performed with near-infrared-guided surgery using indocyanine green (ICG).

Laparoscopic total hysterectomy, bilateral salpingo-oophorectomy (BSO), and sentinel lymph node (SLN) biopsy are executed by 1 of 5 experienced gynecologic oncologists. SLN mapping utilizes indocyanine green (ICG) at a standard concentration of 2.5 mg/mL - 1 mL is injected into the cervix at the 3 and 9 o'clock positions (total dose - 5 mg) to a depth of 5-10 mm, initiated right after general anesthesia induction. Diagnostic laparoscopy employs the Image 1S equipment (KARL STORZ©, Tuttlingen, Germany). Upon examination, fluorescence in the near-infrared spectrum is observed. Successful mapping is indicated by identifying a lymphatic vessel with at least one LN. Detected SLNs are then extracted, and the total hysterectomy with BSO is completed. SLN frozen section remains at the surgeon's discretion. If metastasis surfaces in the SLN either during the frozen section or routine assessment, the option for systematic LN dissection in a subsequent procedure exists although not mandatory.

Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy

While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.

A single-center prospective open-label single-arm clinical trial

[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer

Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial

The rate of change in postoperative treatment based on the SLNB results and postoperative histology (percentage). A change in postoperative treatment strategy is defined as any difference between treatment plans set by the tumor board before and after receiving the SLN biopsy information.

The rate of change in disease stage based on SLNB results and postoperative histology (percentage).

The rate of bilateral SLN detection (percentage).

The actual list of intraoperative complications associated with SLN mapping and biopsy. They include but are not limited to an intraoperative bleeding, small and large bowel injury, ureter and bladder injury, nerve injury, and allergic reaction to indocyanine green (ICG).

Percentage of patients experiencing intraoperative complications associated with SLN mapping and biopsy listed above.

Major postoperative morbidity following the procedure (percentage).

Postoperative mortality following the procedure (percentage).

The rate of lower extremities lymphedema (percentage).

The percentage of patients experiencing pelvic recurrence after surgical treatment.

Time from surgical treatment to detected pelvic recurrence in months.

Moscow City Oncology Hospital No. 62

Determination of the integrated clinicopathological and molecular profile to determine adjuvant treatment: observation for favourable profile; vaginal brachytherapy for intermediate profile; external beam radiotherapy for unfavourable profile

Adjuvant vaginal brachytherapy (standard treatment)

Internal radiation of the vaginal vault using a vaginal cylinder, 21 Gy in 3 out-patient sessions over 2 weeks

External beam pelvic radiotherapy on a linear accelerator, 48.6 Gy in 27 out-patients sessions over 5.5 weeks

No radiation therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment

Carien L. Creutzberg, MD, PhD

Remi A. Nout, MD, PhD

Anne-Sophie van den Heerik, MD

This is prospective, multicenter, randomised phase III trial among women with endometrial cancer with high-intermediate risk features to investigate the role of an integrated clinicopathological and molecular risk profile to determine if participants should receive no adjuvant therapy, vaginal brachytherapy or external beam radiotherapy based on a favourable, intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.

Adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinically relevant reduction of the risk of relapse by the adjuvant treatment. Risk profiles have traditionally been based on clinicopathological factors such as age, stage, grade, LVSI and depth of invasion. Newer, both molecular-genetic (the cancer genome atlas subgroups) or immunohistochemistry-based (L1-CAM) risk factors have become available which are strongly related to outcomes and risk of cancer spread. In a comprehensive analysis of the PORTEC-1 and-2 biobank an integrated clinicopathological and molecular risk profile was determined which separated the current high-intermediate risk group of endometrial cancer in 3 separate groups (favourable, intermediate or unfavourable) with clearly separated outcomes, which is now prospectively tested in the clinic to determine adjuvant treatment. This is the first randomised trial using the molecular risk factors to assign adjuvant treatment for women with stage I-II high-intermediate risk endometrial cancer.

2:1 randomisation to adjuvant treatment assignment based on the integrated molecular risk profile or standard adjuvant vaginal brachytherapy

Evaluation of outcomes is done without information on randomised arm

PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer

Randomised Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Radiotherapy for Women With Early Stage Endometrial Cancer: PORTEC-4a Trial

Specifics will be decided and made public on website at a later stage, most probably from 5 years after final publication onwards

Total vaginal recurrence and vaginal recurrence as first failure

Treatment-related symptoms according to CTCAE v 4.0

Cancer-specific quality of life (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQC-30) - clinically relevant changes on QLQC30 functioning scales, general quality of life and general cancer symptoms

Endometrial cancer-related specific symptoms (EORTC EN24 module)- clinically relevant changes on these scales (quite a bit/very much vs no or mild symptoms)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)	NCT03580421	Endometrial Can... Endometrial Can...	ambulatory surg... standard surger...	18 Years -	Assistance Publique - Hôpitaux de Paris
PROfiling Based Endometrial Cancer Adjuvant Therapy	NCT05179447	Endometrial Can... Endometrial Can...	Vaginal brachyt... External beam r... Observation Chemoradiation ...	18 Years - 75 Years	Women's Hospital School Of Medicine Zhejiang University
PROfiling Based Endometrial Cancer Adjuvant Therapy	NCT05179447	Endometrial Can... Endometrial Can...	Vaginal brachyt... External beam r... Observation Chemoradiation ...	18 Years - 75 Years	Women's Hospital School Of Medicine Zhejiang University
[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer	NCT04972682	Endometrial Can... Endometrial Neo... Endometrial Ade... Endometrial Can... Endometrial Can... Endometrial End... Sentinel Lymph ... Hysterectomy Laparoscopic Hy...	Laparoscopic to...	18 Years -	Moscow City Oncology Hospital No. 62
PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer	NCT03469674	Endometrial Can... Endometrial Can...	Vaginal brachyt... External beam r... Observation	18 Years -	Leiden University Medical Center

Spots Global Cancer Trial Database for endometrial cancer stage ii