Status:
RECRUITING
Sentinel Node Biopsy in Endometrial Cancer
Lead Sponsor:
Queensland Centre for Gynaecological Cancer
Collaborating Sponsors:
The University of Queensland
Conditions:
Endometrial Cancer Stage I
Sentinel Lymph Node
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tube...
Detailed Description
Hypothesis: The primary hypothesis is that SNB will not cause detriment to patients (lymphoedema, morbidity, loss of quality of life) and not increase costs compared to patients without a retroperiton...
Eligibility Criteria
Inclusion
- Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed malignant mullerian 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 as determined by the treating physician (e.g. suitable for TH BSO, ability to tolerate Trendelenberg positioning)
- All available clinical evidence (physical examination findings, or medical imaging such 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, has ONLY Grade 1 EAC and wishes to retain their ovaries).
- Negative (serum or urine) pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause.
Exclusion
- Evidence of extrauterine disease (apparent involvement of cervix, vagina, parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinical examination and/or through medical imaging.
- Enlarged retroperitoneal pelvic and/or aortic lymph nodes (\>1 cm) on medical imaging;
- Estimated life expectancy of less than 6 months;
- Patients who have absolute contraindications for adjuvant radiotherapy and/or chemotherapy;
- Patients who have previously received radiation treatment to the pelvis
- Serious concomitant systemic disorders incompatible with the study (at the discretion 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 node dissection (lymphadenectomy)
- Other prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma of the breast insitu
- Uterine perforation during endometrial tissue sampling
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT04073706
Start Date
January 18 2021
End Date
February 1 2031
Last Update
October 7 2025
Active Locations (20)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Hospital Britanico
Ciudad, Buenos Aires, Argentina
3
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
4
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170