Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas At Intermediate and High Risk of Recurrence.

Launched by CENTRE OSCAR LAMBRET · Nov 4, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a method called the sentinel node policy for women with early-stage endometrial cancer, which is a type of cancer that starts in the lining of the uterus. The trial aims to find out if this new approach is better than current methods used for staging the cancer, particularly for women at intermediate and high risk of the cancer coming back after treatment.

To be eligible for this trial, women must be at least 18 years old and diagnosed with early-stage endometrial cancer that meets specific criteria. This includes certain grades and stages of cancer as defined by medical guidelines. Participants will undergo procedures to help determine their cancer's characteristics, and they will need to provide informed consent to join the study. Throughout the trial, women can expect to receive careful monitoring and support as researchers collect data to see how well the sentinel node policy works. It’s important to note that this trial is currently active but not recruiting new participants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• 1. 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 European Society for Medical Oncology (ESMO) guidelines :
• • Intermediate-risk endometrioid (type 1): FIGO stage IA/T1a grade 3, or IB grade 1 or 2
• • Or High risk endometrioid (type 1) : FIGO stage IB/T1b grade 3, or II grade 1 or 2 or 3
• • Or High risk non endometrioid (type 2) : FIGO stages I-II
• • 2. Without any suspicious pelvic, paraaortic, distant node at preoperative MRI
• • 3. Age ≥ 18 years
• • 4. Performance status (OMS) ≤ 2
• • 5. No contraindication to surgery
• • 6. Absence of known hypersensitivity to colloidal rhenium sulphide and technetium (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
• • 7. Signed and dated informed consent
• • 8. Effective contraception for patients with reproductive potential
• • 9. Patient affiliated with a health insurance system
• Exclusion Criteria:
• 1. Preoperative workup with :
• • Previous hysterectomy (by nature, this trial cannot be offered as a secondary staging procedure)
• • non carcinoma (for example sarcoma, trophoblastic tumor)
• • Low-risk endometrioid carcinoma as defined by the ESMO: 2009 FIGO stage IA grade 1-2
• • Metastatic disease at preoperative workup
• • Suspicious adenopathy at preoperative workup
• • 2. Pregnant and/or breastfeeding woman
• • 3. No understanding of the trial
• • 4. Patient deprived of liberty or in guardianship
• • 5. Inexperience of the trial site in pelvic sentinel node detection