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RANDOMIZED STUDY COMPARING SENTINEL NODE POLICY TO CURRENT INITIAL STAGING PROTOCOLS IN EARLY STAGE ENDOMETRIAL CARCINOMAS AT INTERMEDIATE AND HIGH RISK OF RECURRENCE
EU CTIS ID: 2024-513079-42-00
What this study is testing
To compare the morbidity classified as possibly related to lymph node dissection between the a sentinel node policy (exclusive SN resection complete pelvic lymphadenectomy on SN-negative side) and the national or European protocols of surgical staging, until 3 years of surgery, in intermediate-risk endometrioid and high-risk endometrioid and non-endometrioid carcinomas (full lymphadenectomy: pelvic, paraaortic or both according to stratification)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with early endometrial carcinoma with early FIGO clinical stage I-II (clinical examination, abdomino-pelvic MRI/Ultrasound -or CT scan if MRI not possible- and endometrial biopsy or curettage), then stratification of the recurrence risk as defined by last ESMO guidelines: • Strata A - Intermediate-risk endometrioid (type 1): 2009 FIGO stage IA/T1a grade 3, or IB grade 1 or 2 Or • Strata B - High risk endometrioid (type 1): 2009 FIGO stages IB/T1b, grade 3. FIGO stage II, grade 1 or 2 or 3. Or • Strata C - High risk non endometrioid (type 2): 2009 FIGO stages I-II
- Without any suspicious pelvic, paraaortic, distant node at preoperative MRI (lombo-pelvic MRI or pelvic MRI associated with whole body scintigraphy)
- Age ≥ 18 years
- Performance status (OMS) ≤ 2
- No contraindication to surgery
- Absence of known hypersensitivity: • to colloidal rhenium sulphide and technecium (nanocolloid) or one of its excipients, • to human albumin preparations, to Nanocoll® and Rotop-nanoHSA® and their excipients, • to injectable dyes (blue dye or indocyanine green if available) or one of their excipients, • to triphenylmethane derivatives
You likely can't join if
- Preoperative workup with: - Previous hysterectomy (by nature, this trial cannot be offered as a secondary staging procedure) - Non carcinoma (for exemple sarcoma, trophoblastic tumor) - Low-risk endometrioïd carcinoma as defined by ESMO: 2009 FIGO stage IA grade 1-2 - Metastastic disease at preoperative workup - Suspicious adenopathy at preoperative workup
- Pregnant and/or breastfeeding woman
- No understanding of the trial
- Patient deprived of liberty or in guardianship
- Inexperience of the trial site in pelvic sentinel node detection
See the full eligibility criteria
- Patients with early endometrial carcinoma with early FIGO clinical stage I-II (clinical examination, abdomino-pelvic MRI/Ultrasound -or CT scan if MRI not possible- and endometrial biopsy or curettage), then stratification of the recurrence risk as defined by last ESMO guidelines: • Strata A - Intermediate-risk endometrioid (type 1): 2009 FIGO stage IA/T1a grade 3, or IB grade 1 or 2 Or • Strata B - High risk endometrioid (type 1): 2009 FIGO stages IB/T1b, grade 3. FIGO stage II, grade 1 or 2 or 3. Or • Strata C - High risk non endometrioid (type 2): 2009 FIGO stages I-II
- Without any suspicious pelvic, paraaortic, distant node at preoperative MRI (lombo-pelvic MRI or pelvic MRI associated with whole body scintigraphy)
- Age ≥ 18 years
- Performance status (OMS) ≤ 2
- No contraindication to surgery
- Absence of known hypersensitivity: • to colloidal rhenium sulphide and technecium (nanocolloid) or one of its excipients, • to human albumin preparations, to Nanocoll® and Rotop-nanoHSA® and their excipients, • to injectable dyes (blue dye or indocyanine green if available) or one of their excipients, • to triphenylmethane derivatives
- Signed and dated informed consent
- Effective contraception for patients with reproductive potential
- Patient affiliated with a health insurance system
- Preoperative workup with: - Previous hysterectomy (by nature, this trial cannot be offered as a secondary staging procedure) - Non carcinoma (for exemple sarcoma, trophoblastic tumor) - Low-risk endometrioïd carcinoma as defined by ESMO: 2009 FIGO stage IA grade 1-2 - Metastastic disease at preoperative workup - Suspicious adenopathy at preoperative workup
- Pregnant and/or breastfeeding woman
- No understanding of the trial
- Patient deprived of liberty or in guardianship
- Inexperience of the trial site in pelvic sentinel node detection
The study team makes the final eligibility decision.
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, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.