Sentinel Node Biopsy in Endometrial Cancer

Launched by QUEENSLAND CENTRE FOR GYNAECOLOGICAL CANCER · Aug 27, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new method called sentinel node biopsy (SNB) for women with early-stage endometrial cancer, which is a common type of cancer affecting the uterus. Currently, treatment often involves removing the uterus and possibly other organs to check how far the cancer has spread. The trial aims to find out if SNB, which involves injecting a dye to locate specific lymph nodes, is as effective and safe as traditional lymph node removal. Researchers want to see how this new method affects patients' recovery and whether it leads to less long-term problems, like swelling in the legs (lymphedema).

To participate, women must be over 18 years old, have a confirmed diagnosis of early-stage endometrial cancer, and be in good overall health. They should not have signs of cancer spreading outside the uterus. If eligible, participants will be randomly assigned to either the SNB group or a traditional surgery group. Throughout the study, they will be monitored for their recovery and the status of their cancer over several years. This trial is important because it could help improve treatment options for women with endometrial cancer while reducing potential side effects.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed malignant mullerian tumour);
• • 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:
• • 1. 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.
• • 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