Phase
Condition
Surgery
Endometrial Cancer
Treatment
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
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
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Females, over 18 years, with histologically confirmed primary epithelial cancer ofthe endometrium of any cell type or uterine carcinosarcoma (mixed malignantmullerian tumour);
Clinically stage I disease (disease confined to body of uterus);
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Signed written informed consent;
Participant must meet criteria for a laparoscopic or robotic surgical approach asdetermined by the treating physician (e.g. suitable for TH BSO, ability to tolerateTrendelenberg positioning)
All available clinical evidence (physical examination findings, or medical imagingsuch as CT, MRI or ultrasound) demonstrates no evidence of extrauterine disease
Myometrial Invasion on MRI of not more than 50%. (Only if participant is <45yo, hasONLY Grade 1 EAC and wishes to retain their ovaries).
Negative (serum or urine) pregnancy test ≤ 30 days of surgery in pre-menopausalwomen and women < 2 years after the onset of menopause.
Exclusion
Exclusion Criteria:
Evidence of extrauterine disease (apparent involvement of cervix, vagina,parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinicalexamination and/or through medical imaging.
Enlarged retroperitoneal pelvic and/or aortic lymph nodes (>1 cm) on medicalimaging;
Estimated life expectancy of less than 6 months;
Patients who have absolute contraindications for adjuvant radiotherapy and/orchemotherapy;
Patients who have previously received radiation treatment to the pelvis
Serious concomitant systemic disorders incompatible with the study (at thediscretion of the investigator);
Patient compliance and geographic proximity that do not allow adequate follow-up;
Patients with allergy to Indocyanine Green (ICG)
Patients who have had previous retroperitoneal surgery
Patients who require a retroperitoneal (pelvic +/- para-aortic) lymph nodedissection (lymphadenectomy)
Other prior malignancies <5 years before inclusion, except for successfully treatedkeratinocyte skin cancers, or ductal carcinoma of the breast insitu
Uterine perforation during endometrial tissue sampling
Study Design
Study Description
Connect with a study center
Hospital Britanico
Ciudad, Buenos Aires
ArgentinaSite Not Available
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
St George Hospital
Kogarah, New South Wales 2217
AustraliaSite Not Available
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaSite Not Available
John Hunter Hospital
Newcastle, New South Wales 2305
AustraliaSite Not Available
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
The Wesley Hospital
Auchenflower, Queensland 4066
AustraliaActive - Recruiting
Buderim Private Hospital
Buderim, Queensland 4556
AustraliaActive - Recruiting
Townsville Hospital
Douglas, Queensland 4814
AustraliaSite Not Available
North West Private Hospital
Everton Park, Queensland 4053
AustraliaActive - Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland 4029
AustraliaActive - Recruiting
Mater Hospital
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Gold Coast University Hospital
Southport, Queensland 4215
AustraliaSite Not Available
St Andrews War Memorial Hospital
Spring Hill, Queensland 4000
AustraliaActive - Recruiting
Royal Hobart Hospital
Hobart, Tasmania 7000
AustraliaSite Not Available
Mercy Hospital for Women
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Royal Women's Hospital
Parkville, Victoria 3052
AustraliaActive - Recruiting
Hospital Municipal Vila Santa Catarina
Santa Catarina, Nelson De Sena
BrazilSite Not Available
Liga Paranaense de Combate ao Câncer
Curibita, PR
BrazilSite Not Available
Fundacao Antonio Prudente, AC Camargo Cancer Center
Sao Paulo, SP
BrazilSite Not Available
Hospital Israelita Albert Einstein
Sao Paulo, SP
BrazilSite Not Available
Hospital de Base
São José Do Rio Preto, Sao Paulo 15090-000
BrazilSite Not Available
Instituto Nacional de Cancerología
Astorga, Medellin
ColombiaSite Not Available
Tata Medical Center
Kolkata, Delhi
IndiaSite Not Available
Azienda Sanitaria Universitaria Friuli Centrale (ASUFC)
Udine, Via Pozzuolo 33100
ItalySite Not Available
National University Hospital and National University Cancer Institute
Singapore, NUH Zone B 119074
SingaporeActive - Recruiting
Houston Methodist Hospital
Houston, Texas 77030
United StatesActive - Recruiting
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