NCT04073706Toboroz3. fázis
Sentinel Node Biopsy in Endometrial Cancer
A Phase III Randomised Clinical Trial Comparing Sentinel Node Biopsy With No Retroperitoneal Node Dissection in Apparent Early-Stage Endometrial Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 15.
Rövid összefoglaló (regiszter, angolul)
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)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment \& surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition \& similar to a lymph node dissection, the value to patients, cost effectiveness \& potential harms (e.g. lymphedema) of SNB compared to no-node dissection in EC has never been established. Aim: determine the value of SNB for patients, the healthcare system and exclude detriment to patients using a randomised approach 1:1. Stage 1 - 444 patients. Stage 2 additional 316 patients. 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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 760 (tervezett)
- Első benyújtás
- 2019. aug. 26.
- Kezdés
- 2021. jan. 18.
- Elsődleges befejezés
- 2031. jan.
- Fő szponzor
- Queensland Centre for Gynaecological Cancer
- Betegségek
- Méhtestrák
- NCT-szám
- NCT04073706
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 760
- 2021. jan. 18. és az elsődleges befejezés (2031. jan.) között
- 23 helyszín, 7 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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);
- Patients who have had previous retroperitoneal surgery
Más betegség
- 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.
- Patients with allergy to Indocyanine Green (ICG)
- Uterine perforation during endometrial tissue sampling
Életkor
- Other prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma of the breast insitu
Egyéb
- Enlarged retroperitoneal pelvic and/or aortic lymph nodes (\>1 cm) on medical imaging;
- Estimated life expectancy of less than 6 months;
- Patient compliance and geographic proximity that do not allow adequate follow-up;
- Patients who require a retroperitoneal (pelvic +/- para-aortic) lymph node dissection (lymphadenectomy)
Kiket keres a vizsgálat
- 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 ≤2;
- 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.
Életkor a regiszterben: 18 év – - · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (23)
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