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New treatment option for Endometrial Cancer Stage I
Official title Sentinel Node Biopsy in Endometrial Cancer
ClinicalTrials.gov ID: NCT04073706
What this study is testing
- What it's testing
- 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 tubes, ovaries \& if required a lymph node dissection (surgical staging)).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed...
- 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...
You likely can't join if
- Evidence of extrauterine disease (apparent involvement of cervix, vagina, parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by...
- 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);
See the full eligibility criteria
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), Argentina
- Camperdown, New South Wales, Australia
- Liverpool, New South Wales, Australia
- Auchenflower, Queensland, Australia
- Buderim, Queensland, Australia
- Everton Park, Queensland, Australia
- Herston, Queensland, Australia
- South Brisbane, Queensland, Australia
- Southport, Queensland, Australia
- Spring Hill, Queensland, Australia
- Heidelberg, Victoria, Australia
- Parkville, Victoria, Australia
- São José do Rio Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Bogotá, Bogotá, Distrito Capital, Colombia
- Udine, Via Pozzuolo, Italy
- Singapore, NUH Zone B, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), Argentina; Camperdown, New South Wales, Australia; Liverpool, New South Wales, Australia; Auchenflower, Queensland, Australia; Buderim, Queensland, Australia and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.