LymphadenectomySENTIMETREP53NCT06900582
SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in p53-Mutated Endometrial Cancer: A Non-Inferiority Randomized Trial
A study testing Sentinel Lymph Node Mapping and Comprehensive pelvic and para-aortic lymphadenectomy in people with Lymphadenectomy and Endometrial Cancer, run by University Hospital, Strasbourg, France.
Trial summary
This study evaluates surgical strategies for treating patients with FIGO 2023 stage I and II high-risk endometrial cancer (EC) exhibiting p53 mutations. The trial aims to assess whether a less invasive sentinel lymph node (SLN) mapping approach provides non-inferior oncological outcomes compared to the current… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphadenectomy, Endometrial Cancer, Gene, p53
- What is being tested?
- Sentinel Lymph Node Mapping and Comprehensive pelvic and para-aortic lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 . ≥ 18 years old 2. High-risk endometrial cancer, as defined by the ESGO-ESTRO 20211 histological and molecular classification, with p53 mutation confirmed on endometrial biopsy or curettage in the two months before the surgery 3. Magnetic Resonance Imaging (MRI) confirmed FIGO 2023 stage I and II endometrial cancer, i.e., confined to the uterine corpus, ovary and the cervical stroma.
- 4. Participant with a scheduled surgical intervention (total hysterectomy and bilateral salpingo-oophorectomy, with omentectomy in the case of serous, carcinosarcoma and undifferenciated type EC) 5. Eligible for comprehensive lymphadenectomy by laparoscopy 6. Participant with a negative Positron Emission Tomography scan (PET-CT scan) for lymph node involvement in the two months before the intervention 7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1 8. Participant able to provide written informed consent
Who cannot join
- Recurrent EC
- Previous chemo-, radio, or endocrine therapy for EC
- Any contra-indication to lymphadenectomy and/or chemotherapy
- Any contraindication to laparoscopy
- Any criteria, based on the investigator's judgment, that would contraindicate the surgical procedure (e.g., but not limited to, anesthetic risk, bleeding, significant comorbidities)
- Any known disorder or circumstances making participation in trial and follow-up questionable
Show all 13Show fewer
- Patients with other malignancies for whom the disease(s) and/or associated treatment(s) might have an impact on the patient's cancer prognosis
- Known HIV-infection or AIDS
- Simultaneous participation in another interventional clinical trial
- Within the exclusion period following participation in another interventional clinical trial
- Patients with difficulties in reading or understanding French, or an inability to understand the delivered information
- Patients in emergency medical situations
- Patient under guardianship or limited guardianship
About this study
Official title: Comparing SENTInel Node Mapping to Comprehensive Lymphadenectomy in p53-Mutated EndoMETRial Cancer: a Prospective, Open-label, Controlled, Randomized, Non-inferiority, De-escalation Trial
This study evaluates surgical strategies for treating patients with FIGO 2023 stage I and II high-risk endometrial cancer (EC) exhibiting p53 mutations. The trial aims to assess whether a less invasive sentinel lymph node (SLN) mapping approach provides non-inferior oncological outcomes compared to the current standard of systematic pelvic and para-aortic lymphadenectomy (PL+PALND). By minimizing surgical morbidity, this study seeks to determine if SLN mapping can safely replace comprehensive lymphadenectomy without compromising disease-free survival (DFS). Eligible patients will be randomized to undergo either sentinel lymph node mapping or complete lymphadenectomy, followed by standard hysterectomy and bilateral salpingo-oophorectomy. The primary outcome is DFS at 36 months, with secondary outcomes including overall survival, disease-specific survival, perioperative complications, and quality of life.
Read the detailed description
The necessity of extensive lymph node dissection in endometrial cancer remains a subject of debate. Although systematic pelvic and para-aortic lymphadenectomy (PL+PALND) improves disease staging and influences adjuvant therapy, its impact on survival in high-risk endometrial cancer (EC) is still controversial. Recent evidence suggests that SLN mapping may provide comparable staging accuracy while reducing surgical complications. However, the oncological safety of replacing PL+PALND with SLN mapping in high-risk EC patients, particularly those with p53 mutations, remains uncertain.
This study is designed as a prospective, multicenter, randomized controlled trial to evaluate the non-inferiority of SLN mapping versus PL+PALND in patients with high-risk EC characterized by p53 mutations. Patients will be stratified based on tumor histology and imaging findings before undergoing surgery. The trial will enroll 374 patients across 22 participating centers.
Key issues addressed include:
- Oncological Safety: Assessing whether SLN mapping provides equivalent DFS compared to PL+PALND.
- Survival Outcomes: Evaluating overall survival (OS) and disease-specific survival (DSS) at 36 months.
- Surgical Morbidity: Comparing perioperative and postoperative complications
- Quality of Life: Determining patient-reported outcomes related to surgical recovery and long-term functional status.
This study integrates modern molecular classifications, recognizing p53 mutations as a significant prognostic marker. If SLN mapping is proven non-inferior, it could lead to a paradigm shift, reducing the extent of surgical intervention for high-risk EC patients while maintaining oncological safety.
- Being tested
- Sentinel Lymph Node Mapping, Comprehensive pelvic and para-aortic lymphadenectomy
- Keywords
- Endometrial cancer, Sentinel lymph node biopsy, Lymphadenectomy, p53 mutation
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node MappingProcedure or surgery
The SLN mapping protocol will follow the EU guidelines and the consensus in competency assessment tool. Prior to SLN mapping, a full inspection of the pelvic areas with white light is performed to exclude the presence of extrauterine disease. The next surgical steps will be 1- identification of external iliac vessels, 2- identification of internal iliac artery, 3- dissection of the ureter, 4- development of paravesical space and 5- identification of obliterated umbilical ligament. The dissection technique must avoid disrupting lymphatic channels and isolate nodal tissue from the local anatomy. Indocyanine green (1.25mg/mL) will be injected in the cervix at the 3 and 9 o'clock positions, with 1mL superficial and 1mL deep, for a total of 4mL. All mapped SLNs must be completely excised, and any visually suspicious nodes should also be removed, regardless of the mapping results. If the SLN mapping appears to be unfeasible, a side-specific pelvic lymphadenectomy will be performed.
Comprehensive pelvic and para-aortic lymphadenectomyProcedure or surgery
The resection of at least one lymph node in each of the 12 retroperitoneal regions is necessary:
A: upper para-aortic region B: lower para-aortic region C: interaorto-caval region D: paracaval region E: right and left iliaca communis region F: right and left iliaca externa region G: right and left fossa obturatoria region: defined by external and internal arteria iliaca, pelvic sidewall H: right and left iliaca interna region: lymph nodes adjacent to or medial of the internal iliacal artery
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Lymph Node Mapping | Experimental | Patients in this arm will undergo sentinel lymph node (SLN) mapping, followed by total hysterectomy, bilateral salpingo-oophorectomy, and, for serous, carcinosarcoma and undifferentiated type EC, infracolic omentectomy. The determination to perform para-aortic lymphadenectomy on SLN+ patients is left to the clinical team. Adjuvant treatment will depend of the status. Receives: Procedure: Sentinel Lymph Node Mapping |
| Complete lymphadenectomy | Active comparator | Patients in this arm will undergo comprehensive pelvic and para-aortic lymphadenectomy that extends up to the left renal vein, followed by total hysterectomy and bilateral salpingo-oophorectomy, with omentectomy for serous, carcinosarcoma and undifferentiated type EC. Adjuvant treatment will depend of the status. Receives: Procedure: Comprehensive pelvic and para-aortic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free-survival (DFS)
Time from randomization to first recurrence or death from any cause, censored at last follow-up
Measured: 36 months
Secondary outcomes (8)
Overall survival (OS)
Time from randomization to death due to endometrial cancer, censored for other deaths/last follow-up.
Measured: 36 months
Disease-specific survival (DSS)
Time from randomization to death due to endometrial cancer,
Measured: 36 Months
Perioperative complications rate and postoperative complications rate
The classification of Clavien-Dindo will be used.
Measured: At 30- and 90-days
Return to intended oncologic treatment (RIOT)
Time in days between the date of surgery and the first day of adjuvant treatment.
Measured: From the date of surgery (Day 0) until the first day of adjuvant treatment, assessed up to 90 days.
Quality of life - EORTC QLQ-C30 questionnaire score
EORTC QLQ-C30 questionnaire is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients
Measured: At baseline, 1, 6 and 12 months
Quality of life - EORTC QLQ-EN24 questionnaire score
EORTC QLQ-EN24 questionnaire is designed to assess disease and treatment specific aspects of the quality of life of patients with endometrial cancer
Measured: At baseline, 1, 6 and 12 months
Accuracy of PET-CT scan in the detection of metastatic lymph nodes
Determination of the sensitivity, specificity, positive and negative predictive value
Measured: From Day -60 to Day -1 before surgery (Day 0)
Assessment of the rate of unsuccessful SLN mapping, requiring conversion to pelvic lymphadenectomy
Rate of unsuccessful SLN mapping, requiring conversion to pelvic lymphadenectomy
Measured: At surgery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study startJun 2026 (estimated)
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphadenectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900582
- Sponsor's protocol ID
- 9423
- Acronym
- SENTIMETREP53
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akladios C, Lecointre L, Lefebvre F, Eberst L, Menoux I, Ouldamer L, Lavoue V, Huchon C, Dabi Y, Gertych W, Guyon F, Laas E, Bonneau C, Kerbage Y, Chauleur C, Fauvet R, Brun JL, Raimond E, Gauthier T, Costaz H, Rouzier R, Hotton J, Marchal F, Loaec C, Ramanah R, Chopin N, Querleu D, Jochum F. Comparison of sentinel lymph node mapping with comprehensive lymphadenectomy in p53-mutated endometrial cancer: a prospective, multi-center, non-inferiority, open-label, de-escalation, randomized, controlled trial (Study Protocol - SENTIMETREP53). Int J Gynecol Cancer. 2026 Feb 6:104547. doi: 10.1016/j.ijgc.2026.104547. Online ahead of print.
PubMed 41796475
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing SENTInel Node Mapping to Comprehensive Lymphadenectomy in p53-Mutated EndoMETRial Cancer: a Prospective, Open-label, Controlled, Randomized, Non-inferiority, De-escalation Trial
- ClinicalTrials.gov ID
- NCT06900582
- Acronym / sponsor ID
- SENTIMETREP53 / 9423
- Keywords
- Endometrial cancer, Sentinel lymph node biopsy, Lymphadenectomy, p53 mutation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates surgical strategies for treating patients with FIGO 2023 stage I and II high-risk endometrial cancer (EC) exhibiting p53 mutations. The trial aims to assess whether a less invasive sentinel lymph node (SLN) mapping approach provides non-inferior oncological outcomes compared to the current standard of systematic pelvic and para-aortic lymphadenectomy (PL+PALND). By minimizing surgical morbidity, this study seeks to determine if SLN mapping can safely replace comprehensive lymphadenectomy without compromising disease-free survival (DFS). Eligible patients will be randomized to undergo either sentinel lymph node mapping or complete lymphadenectomy, followed by standard hysterectomy and bilateral salpingo-oophorectomy. The primary outcome is DFS at 36 months, with secondary outcomes including overall survival, disease-specific survival, perioperative complications, and quality of life.
Detailed description
The necessity of extensive lymph node dissection in endometrial cancer remains a subject of debate. Although systematic pelvic and para-aortic lymphadenectomy (PL+PALND) improves disease staging and influences adjuvant therapy, its impact on survival in high-risk endometrial cancer (EC) is still controversial. Recent evidence suggests that SLN mapping may provide comparable staging accuracy while reducing surgical complications. However, the oncological safety of replacing PL+PALND with SLN mapping in high-risk EC patients, particularly those with p53 mutations, remains uncertain.
This study is designed as a prospective, multicenter, randomized controlled trial to evaluate the non-inferiority of SLN mapping versus PL+PALND in patients with high-risk EC characterized by p53 mutations. Patients will be stratified based on tumor histology and imaging findings before undergoing surgery. The trial will enroll 374 patients across 22 participating centers.
Key issues addressed include:
- Oncological Safety: Assessing whether SLN mapping provides equivalent DFS compared to PL+PALND.
- Survival Outcomes: Evaluating overall survival (OS) and disease-specific survival (DSS) at 36 months.
- Surgical Morbidity: Comparing perioperative and postoperative complications
- Quality of Life: Determining patient-reported outcomes related to surgical recovery and long-term functional status.
This study integrates modern molecular classifications, recognizing p53 mutations as a significant prognostic marker. If SLN mapping is proven non-inferior, it could lead to a paradigm shift, reducing the extent of surgical intervention for high-risk EC patients while maintaining oncological safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel Lymph Node Mapping | Experimental | Procedure: Sentinel Lymph Node MappingPatients in this arm will undergo sentinel lymph node (SLN) mapping, followed by total hysterectomy, bilateral salpingo-oophorectomy, and, for serous, carcinosarcoma and undifferentiated type EC, infracolic omentectomy. The determination to perform para-aortic lymphadenectomy on SLN+ patients is left to the clinical team. Adjuvant treatment will depend of the status. |
| Complete lymphadenectomy | Active comparator | Procedure: Comprehensive pelvic and para-aortic lymphadenectomyPatients in this arm will undergo comprehensive pelvic and para-aortic lymphadenectomy that extends up to the left renal vein, followed by total hysterectomy and bilateral salpingo-oophorectomy, with omentectomy for serous, carcinosarcoma and undifferentiated type EC. Adjuvant treatment will depend of the status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1 . ≥ 18 years old 2. High-risk endometrial cancer, as defined by the ESGO-ESTRO 20211 histological and molecular classification, with p53 mutation confirmed on endometrial biopsy or curettage in the two months before the surgery 3. Magnetic Resonance Imaging (MRI) confirmed FIGO 2023 stage I and II endometrial cancer, i.e., confined to the uterine corpus, ovary and the cervical stroma.
- 4. Participant with a scheduled surgical intervention (total hysterectomy and bilateral salpingo-oophorectomy, with omentectomy in the case of serous, carcinosarcoma and undifferenciated type EC) 5. Eligible for comprehensive lymphadenectomy by laparoscopy 6. Participant with a negative Positron Emission Tomography scan (PET-CT scan) for lymph node involvement in the two months before the intervention 7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1 8. Participant able to provide written informed consent
Key exclusion criteria (13 listed)
- Recurrent EC
- Previous chemo-, radio, or endocrine therapy for EC
- Any contra-indication to lymphadenectomy and/or chemotherapy
- Any contraindication to laparoscopy
- Any criteria, based on the investigator's judgment, that would contraindicate the surgical procedure (e.g., but not limited to, anesthetic risk, bleeding, significant comorbidities)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Lymph Node MappingThe SLN mapping protocol will follow the EU guidelines and the consensus in competency assessment tool. Prior to SLN mapping, a full inspection of the pelvic areas with white light is performed to exclude the presence of extrauterine disease. The next surgical steps will be 1- identification of external iliac vessels, 2- identification of internal iliac artery, 3- dissection of the ureter, 4- development of paravesical space and 5- identification of obliterated umbilical ligament. The dissection technique must avoid disrupting lymphatic channels and isolate nodal tissue from the local anatomy. Indocyanine green (1.25mg/mL) will be injected in the cervix at the 3 and 9 o'clock positions, with 1mL superficial and 1mL deep, for a total of 4mL. All mapped SLNs must be completely excised, and any visually suspicious nodes should also be removed, regardless of the mapping results. If the SLN mapping appears to be unfeasible, a side-specific pelvic lymphadenectomy will be performed. | Procedure or surgery | Sentinel Lymph Node Mapping |
| Comprehensive pelvic and para-aortic lymphadenectomyThe resection of at least one lymph node in each of the 12 retroperitoneal regions is necessary: A: upper para-aortic region B: lower para-aortic region C: interaorto-caval region D: paracaval region E: right and left iliaca communis region F: right and left iliaca externa region G: right and left fossa obturatoria region: defined by external and internal arteria iliaca, pelvic sidewall H: right and left iliaca interna region: lymph nodes adjacent to or medial of the internal iliacal artery | Procedure or surgery | Complete lymphadenectomy |
Primary outcome
Disease-free-survival (DFS)
Time frame: 36 months
Time from randomization to first recurrence or death from any cause, censored at last follow-up
8 secondary outcomes
Overall survival (OS)
Time frame: 36 months
Disease-specific survival (DSS)
Time frame: 36 Months
Perioperative complications rate and postoperative complications rate
Time frame: At 30- and 90-days
Return to intended oncologic treatment (RIOT)
Time frame: From the date of surgery (Day 0) until the first day of adjuvant treatment, assessed up to 90 days.
Quality of life - EORTC QLQ-C30 questionnaire score
Time frame: At baseline, 1, 6 and 12 months
Quality of life - EORTC QLQ-EN24 questionnaire score
Time frame: At baseline, 1, 6 and 12 months
Accuracy of PET-CT scan in the detection of metastatic lymph nodes
Time frame: From Day -60 to Day -1 before surgery (Day 0)
Assessment of the rate of unsuccessful SLN mapping, requiring conversion to pelvic lymphadenectomy
Time frame: At surgery time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 41796475Akladios C, Lecointre L, Lefebvre F, Eberst L, Menoux I, Ouldamer L, Lavoue V, Huchon C, Dabi Y, Gertych W, Guyon F, Laas E, Bonneau C, Kerbage Y, Chauleur C, Fauvet R, Brun JL, Raimond E, Gauthier T, Costaz H, Rouzier R, Hotton J, Marchal F, Loaec C, Ramanah R, Chopin N, Querleu D, Jochum F. Comparison of sentinel lymph node mapping with comprehensive lymphadenectomy in p53-mutated endometrial cancer: a prospective, multi-center, non-inferiority, open-label, de-escalation, randomized, controlled trial (Study Protocol - SENTIMETREP53). Int J Gynecol Cancer. 2026 Feb 6:104547. doi: 10.1016/j.ijgc.2026.104547. Online ahead of print.
Related trials for Lymphadenectomy
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
Not yet recruitingPhase 1/2
RYZ711 Diagnostic Platform Study
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RecruitingPhase 2
Phase II Study of Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT for BTC With Lymph Node Metastases
Biliary Tract Cancer (BTC), Surgery
Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Lymphedema, Breast Cancer
Not yet recruiting
27-Inch Versus 55-Inch Monitors in Women Undergoing Endometrial Cancer Surgery
Endometrial Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Lymph Node Mapping and Comprehensive pelvic and para-aortic lymphadenectomy in people with Lymphadenectomy and Endometrial Cancer, run by University Hospital, Strasbourg, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free-survival (DFS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06900582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.