Study Results
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Basic Information
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RECRUITING
PHASE3
760 participants
INTERVENTIONAL
2021-01-18
2031-02-28
Brief Summary
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Primary Outcome Stage 1:
Proportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities.
Primary Outcome Stage 2:
Treatment non-inferiority as evaluated by disease-free survival status at 4.5 years post-surgery, as measured by the time interval between the date of randomisation and date of first recurrence. Confirmation of recurrent disease will be ascertained through clinical assessment, radiological work-up and/or histological results.
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Detailed Description
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Aims: To determine the value of SNB for patients, the healthcare system and to exclude detriment to patients.
Objectives:
Primary Stage 1:
To determine the recovery of participants (defined as incidence of adverse events, lower limb lymphoedema and health-related QOL) and to the healthcare system (cost) of Sentinel Node Biopsy (SNB) for the surgical treatment of endometrial cancer.
Primary Stage 2:
Compare disease-free survival at 4.5 years for participants randomised to receive hysterectomy, bilateral salpingo-oophorectomy with SNB compared to participants randomised to hysterectomy, bilateral salpingo-oophorectomy without retroperitoneal node dissection.
Secondary:
* Compare patterns of recurrence and overall survival (OS) between the groups
* Determine the cost-effectiveness of SNB
* Compare Patient Reported Outcomes (PROMS) between the groups at 12 months from surgery
* Compare Health Related Quality of Life (HRQL) and Fear of Recurrence between the groups at 12 months from surgery
* Compare perioperative outcomes (duration of surgery, length of hospital stay, intraoperative blood loss, blood transfusion requirements) and the incidence of intra- and postoperative adverse events within 12 months from surgery between the groups
* Compare lower limb lymphoedema at 12 months after surgery
* Compare the need for postoperative (adjuvant) treatments between groups
* Determine the impact of body composition and frailty on survival, quality of life, lymphoedema, peri-, intra- and postoperative outcomes
* Compare follow-up strategies (clinical vs symptom checklist)
* Translational Research - Trans-ENDO 3 - biobanking strategy - Compare the Molecular profile at 12 months from surgery between the groups
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TH BSO with SNB
Total Laparoscopic/Robotic Hysterectomy, Bilateral Salpingo-Oophorectomy (TH BSO) with Sentinel Node Biopsy (SNB) using Indocyanine Green (ICG)+/- Methylene Blue Dye (+/- omentectomy in high risk cell types) Note: If participants (≤45 years of age), have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion \<50% (by MRI) and wish to retain their ovaries a BSO may be omitted.
TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Removal of uterus, tubes and ovaries with a sentinel node biopsy. A tracer dye (ICG) +/- Methylene Blue Dye is injected into the surroundings of the primary tumour, it is transported via local lymphatic channels towards the draining lymphatic basin, and the first node that the tracer reaches is called the "sentinel node". These one or two nodes are thought to be first involved with cancer spread.
TH BSO without retroperitoneal node dissection
Total Laparoscopic/Robotic Hysterectomy, Bilateral Salpingo-Oophorectomy (TH BSO) without retroperitoneal node dissection (+/- omentectomy in high risk cell types) Note: If participants (≤45 years of age), have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion \<50% (by MRI) and wish to retain their ovaries a BSO may be omitted.
TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Removal of uterus, tubes and ovaries without retroperitoneal node dissection
Interventions
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TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Removal of uterus, tubes and ovaries with a sentinel node biopsy. A tracer dye (ICG) +/- Methylene Blue Dye is injected into the surroundings of the primary tumour, it is transported via local lymphatic channels towards the draining lymphatic basin, and the first node that the tracer reaches is called the "sentinel node". These one or two nodes are thought to be first involved with cancer spread.
TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
Removal of uterus, tubes and ovaries without retroperitoneal node dissection
Eligibility Criteria
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Inclusion Criteria
2. Clinically stage I disease (disease confined to body of uterus);
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. Signed written informed consent;
5. Participant must meet criteria for a laparoscopic or robotic surgical approach as determined by the treating physician (e.g. suitable for TH BSO, ability to tolerate Trendelenberg positioning)
6. All available clinical evidence (physical examination findings, or medical imaging such as CT, MRI or ultrasound) demonstrates no evidence of extrauterine disease
7. Myometrial Invasion on MRI of not more than 50%. (Only if participant is \<45yo, has ONLY Grade 1 EAC and wishes to retain their ovaries).
8. Negative (serum or urine) pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause.
Exclusion Criteria
2. Enlarged retroperitoneal pelvic and/or aortic lymph nodes (\>1 cm) on medical imaging;
3. Estimated life expectancy of less than 6 months;
4. Patients who have absolute contraindications for adjuvant radiotherapy and/or chemotherapy;
5. Patients who have previously received radiation treatment to the pelvis
6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
7. Patient compliance and geographic proximity that do not allow adequate follow-up;
8. Patients with allergy to Indocyanine Green (ICG)
9. Patients who have had previous retroperitoneal surgery
10. Patients who require a retroperitoneal (pelvic +/- para-aortic) lymph node dissection (lymphadenectomy)
11. Other prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma of the breast insitu
12. Uterine perforation during endometrial tissue sampling
18 Years
FEMALE
No
Sponsors
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The University of Queensland
OTHER
Queensland Centre for Gynaecological Cancer
OTHER_GOV
Responsible Party
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Principal Investigators
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Andreas Obermair, Prof
Role: STUDY_CHAIR
Director, Queensland Centre for Gynaecological Cancer Research
Locations
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Houston Methodist Hospital
Houston, Texas, United States
Hospital Britanico
Ciudad, Buenos Aires, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
The Wesley Hospital
Auchenflower, Queensland, Australia
Buderim Private Hospital
Buderim, Queensland, Australia
North West Private Hospital
Everton Park, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Mater Hospital
South Brisbane, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
St Andrews War Memorial Hospital
Spring Hill, Queensland, Australia
Mercy Hospital for Women
Heidelberg, Victoria, Australia
Royal Women's Hospital
Parkville, Victoria, Australia
Hospital Municipal Vila Santa Catarina
Santa Catarina, Nelson de Sena, Brazil
Hospital de Base
São José do Rio Preto, São Paulo, Brazil
Fundacao Antonio Prudente, AC Camargo Cancer Center
São Paulo, São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Instituto Nacional de Cancerología
Astorga, Medellin, Colombia
Azienda Sanitaria Universitaria Friuli Centrale (ASUFC)
Udine, Via Pozzuolo, Italy
National University Hospital and National University Cancer Institute
Singapore, NUH Zone B, Singapore
Countries
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Central Contacts
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Facility Contacts
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Renato
Role: backup
Renato
Role: backup
References
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Obermair A, Nicklin J, Gebski V, Hayes SC, Graves N, Mileshkin L, Lin MY, Beale P, Baxter E, Robledo K, Salomon C, Hanna GB, Janda M. A phase III randomized clinical trial comparing sentinel node biopsy with no retroperitoneal node dissection in apparent early-stage endometrial cancer - ENDO-3: ANZGOG trial 1911/2020. Int J Gynecol Cancer. 2021 Dec;31(12):1595-1601. doi: 10.1136/ijgc-2021-003029. Epub 2021 Nov 2.
Other Identifiers
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ENDO-3
Identifier Type: -
Identifier Source: org_study_id
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