Endometrial CancerALICENCT03366051
Sentinel Node Mapping in High Risk Endometrial Cancer
A study testing Sentinel Node Mapping and Lymphadenectomy in people with Endometrial Cancer and Lymph Node Metastases, run by AC Camargo Cancer Center at 5 sites in Brazil.
Trial summary
This study will evaluate the role of systematic lymphadenectomy after sentinel node (SLN) mapping in high risk endometrial cancer (high grade histologies or deep myometrial invasion). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Endometrial Cancer, Lymph Node Metastases
- What is being tested?
- Sentinel Node Mapping and Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 5 sitesBrazil
- Study dates
- 22 Dec 2017to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High grade histologies (endometrioid grade 3, serous, clear cell and carcinosarcoma)
- Endometrioid grades 1 or 2 with myometrial invasion of ≥50%
- Endometrioid grades 1 or 2 with cervical invasion
- Clinically suitable to receive systematic lymphadenectomy
- Consent statement
Who cannot join
- Previous hysterectomy in other institution
- Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis)
- Previous pelvic node dissection
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites, 5 recruiting
- Recruiting
Hospital do Cancer de Barretos
Barretos, São Paulo
Carlos Andrade, MD, PhD, mdcarlosandrade@gmail.com
- Recruiting
Hospital Erasto Gaertner
Curitiba, Paraná
Reitan Ribeiro, MD, reitanribeiro@hotmail.com
- Recruiting
AC Camargo Cancer Center
São Paulo, São Paulo, 01509010
Glauco Baiocchi, MD, PhD, 551121895110, glauco.baiocchi@accamargo.org.br
- Recruiting
Albert Einstein Hospital
São Paulo, São Paulo
Renato Moretti-Marques, MD, PhD, morettimarques@gmail.com
- Recruiting
Sao Camilo Oncologia
São Paulo, São Paulo
Andre Lopes, MD, PhD, andrelopes.cirurgia@gmail.com
About this study
Official title: Sentinel Node Mapping Versus Sentinel Node Mapping With Systematic Lymphadenectomy in High Risk Endometrial Cancer: a Open Label, Non-inferiority, Randomized Trial.
This study will evaluate the role of systematic lymphadenectomy after sentinel node (SLN) mapping in high risk endometrial cancer (high grade histologies or deep myometrial invasion). The participants will be randomized in a non-inferiority controlled trial in 2 groups: SLN mapping or SLN mapping followed by systematic lymphadenectomy.
Read the detailed description
Although most patients with endometrial cancer present with early-stage disease, the standard treatment still includes systematic lymph node dissection for staging. Recently, SLN mapping has emerged as an acceptable surgical strategy when deciding between complete lymphadenectomy and no node dissection. This approach can help avoid the morbidity that is associated with a complete lymphadenectomy, such as neurovascular injury, lymphocyst formation, and lymphedema. A recent meta-analysis that included 55 studies and 4915 patients reported an overall SLN detection rate of 81% versus 50% for bilateral SLNs. Moreover, the use of indocyanine green increased the bilateral SLN detection rate compared with blue dye (74.6% vs. 50.5%). Yet, the studies noted an overall sensitivity of 96% and false negative rates of less than 5% when analyzed per hemipelvis. Since 2014, the National Comprehensive Cancer Network (NCCN) guidelines have recommended SLN mapping as an alternative option for node staging in endometrial cancer. However, most studies on SLN mapping have included patients who are at low risk for lymph node involvement and thus might underestimate the false negative rate. Recently, Soliman et al. reported a series of only high-grade and deep invasive endometrial cancers for which patients underwent SLN mapping, followed by pelvic and para-aortic lymph node dissection. An 89% detection rate was reported, suggesting that SLN mapping accurately identifies node metastases, with an negative predictive value (NPV) of 98% and an false negative predictive value (FNPV) of 2% when analyzed by hemipelvises. Positive nodes were found in 22.8% of patients (43% of isolated tumor cells and micrometastases), and in 40% of cases, the SLN was the only positive node. Data from the investigators corroborate these findings-26.7% of high-risk cases had positive nodes (50% of isolated tumor cells and micrometastases), and when analyzed by hemipelvis, the NPV was 97.9% and the FNPV was 2.1%. In 14 (70%) patients, the SLN was the only positive node. Moreover, there are few publications that have compared the results of the addition of SLN mapping to lymphadenectomy alone. Raimond et al. compared 156 patients that had SLN mapping with 95 who had pelvic node dissection. In their study, SLN mapping and imuno-histochemistry (IHC) were performed in low- and intermediate-risk patients, and the former detected metastatic node 3 times more often than complete pelvic lymphadenectomy alone (16.2% vs. 5.1%, p=0.03). They had no false negatives, and the IHC findings modified the adjuvant therapy in half of all cases. Holloway et al. compared a series of 661 patients who had undergone pelvic and para-aortic lymphadenectomy with 119 who were subjected to SLN mapping plus node dissection, including 68 high-intermediate- and high-risk patients in the SLN mapping group (GOG99 stratification). Despite the similarity in demographics and pathological risk factors, the SLN group had more LN metastases that were detected (30.3% vs. 16.3%; p<0.001) and received more adjuvant therapy (28.6% vs. 16.3%; p=0.003). The SLN was the only positive node in 18 (50%) of mapped cases, and the false negative rate was 2.8%.The investigators recently published a series on high risk endometrial cancer and also recorded a higher pelvic node metastasis rate for the SLN mapping group (26.7% vs. 14.3%, p=0.02) but no significant difference in para-aortic node metastases (13.5% vs. 5.6%, p=0.12). Notably, if considered only patients in whom SLNs were mapped, 31.3% had pelvic positive nodes. Despite the differences in uterine risk factors between groups, 10.6% (8/75) of patients in the SLN group had node metastasis that was diagnosed only after IHC. Excluding these patients, the SLN group would have had a node positivity rate of 17.3%, similar to the N-SLN group (17.4%), reinforcing the impact of IHC in the detection of node metastases. Moreover, the SLN group received more adjuvant chemotherapy (33.5% vs. 48%). The overall detection rate for SLNs was 85.3%, and bilateral SLNs were observed in 60%. The investigators noted an overall sensitivity of 90%, a negative predictive value of 95.7%, and a false negative predictive value of 4.3%. Recently, Touhami et al. showed that the risk of non-SLN metastasis is 61% when the SLN metastasis size is ≥2mm, and 5% for SLN metastasis of <2mm. However, one of the remaining uncertainties is the role of systematic lymphadenectomy after a positive SLN. In other words, is there any benefit in favor of systematic lymphadenectomy in a patient that already undergo adjuvant chemotherapy? The investigators hypothesized that there is no disease free survival benefit in adding systematic lymphadenectomy to only sentinel node mapping and proposed a prospective randomized controlled non-inferiority trial comparing SLN mapping to SLN mapping with systematic lymphadenectomy in high risk endometrial cancer.
- Conditions
- Endometrial Cancer, Lymph Node Metastases
- Being tested
- Sentinel Node Mapping, Lymphadenectomy
- Keywords
- Endometrial Cancer, Sentinel Lymph Node, Lymphadenectomy
- Medical subject headings
- Endometrial Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Node MappingProcedure or surgery
At least one sentinel node should be retrieved in both hemipelvis. If no sentinel node is found in one hemipelvis, a side specific lymphadenectomy will be performed.
LymphadenectomyProcedure or surgery
Systematic Pelvic and Para-Aortic Lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Node Mapping plus Lymphadenectomy | Active comparator | Patients with high risk endometrial cancer will undergo Sentinel Node Mapping followed by Systematic Pelvic and Para-Aortic Lymphadenectomy Receives: Procedure: Sentinel Node Mapping; Procedure: Lymphadenectomy |
| Sentinel Node Mapping | Experimental | Patients with high risk endometrial cancer will undergo Sentinel Node Mapping per NCCN algorithm Receives: Procedure: Sentinel Node Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence Free Survival
Measured: 3 years
Secondary outcomes (5)
Survival
Overall Survival
Measured: 5 years
Early morbidity
Surgical and clinical morbidity
Measured: <30 days after surgery
Late morbidity
Surgical and clinical morbidity
Measured: >30 days after surgery
Lymphedema
Presence and lymphedema graduation
Measured: Evaluation before surgery and after 6 and 12 months of follow-up
Quality of Life Questionary (QLQ)
EORTC QLQ-C30
Measured: Evaluation before surgery and after 1 and 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start22 Dec 2017
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies 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
- Model description
- Randomized Controlled Non-Inferiority Trial
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glauco Baiocchi Neto, AC Camargo Cancer Center
- Investigators
- Glauco Baiocchi, MD, PhD, Principal investigator, Department of Gynecologic Oncology - AC Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366051
- Sponsor's protocol ID
- 2.392.088
- Acronym
- ALICE
- Status last verified
- Jul 2024
- First submitted
- 4 Dec 2017
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baiocchi G, Mantoan H, Kumagai LY, Goncalves BT, Badiglian-Filho L, de Oliveira Menezes AN, Faloppa CC, De Brot L, da Costa AABA. The Impact of Sentinel Node-Mapping in Staging High-Risk Endometrial Cancer. Ann Surg Oncol. 2017 Dec;24(13):3981-3987. doi: 10.1245/s10434-017-6132-8. Epub 2017 Oct 20.
PubMed 29058141Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.
PubMed 28566221Holloway RW, Gupta S, Stavitzski NM, Zhu X, Takimoto EL, Gubbi A, Bigsby GE, Brudie LA, Kendrick JE, Ahmad S. Sentinel lymph node mapping with staging lymphadenectomy for patients with endometrial cancer increases the detection of metastasis. Gynecol Oncol. 2016 May;141(2):206-210. doi: 10.1016/j.ygyno.2016.02.018. Epub 2016 Mar 2.
PubMed 26905211Soliman PT, Westin SN, Dioun S, Sun CC, Euscher E, Munsell MF, Fleming ND, Levenback C, Frumovitz M, Ramirez PT, Lu KH. A prospective validation study of sentinel lymph node mapping for high-risk endometrial cancer. Gynecol Oncol. 2017 Aug;146(2):234-239. doi: 10.1016/j.ygyno.2017.05.016. Epub 2017 May 18.
PubMed 28528918Rossi EC, Kowalski LD, Scalici J, Cantrell L, Schuler K, Hanna RK, Method M, Ade M, Ivanova A, Boggess JF. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol. 2017 Mar;18(3):384-392. doi: 10.1016/S1470-2045(17)30068-2. Epub 2017 Feb 1.
PubMed 28159465Bodurtha Smith AJ, Fader AN, Tanner EJ. Sentinel lymph node assessment in endometrial cancer: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 May;216(5):459-476.e10. doi: 10.1016/j.ajog.2016.11.1033. Epub 2016 Nov 18.
PubMed 27871836Abu-Rustum NR. Sentinel lymph node mapping for endometrial cancer: a modern approach to surgical staging. J Natl Compr Canc Netw. 2014 Feb;12(2):288-97. doi: 10.6004/jnccn.2014.0026.
PubMed 24586087Raimond E, Ballester M, Hudry D, Bendifallah S, Darai E, Graesslin O, Coutant C. Impact of sentinel lymph node biopsy on the therapeutic management of early-stage endometrial cancer: Results of a retrospective multicenter study. Gynecol Oncol. 2014 Jun;133(3):506-11. doi: 10.1016/j.ygyno.2014.03.019. Epub 2014 Mar 15.
PubMed 24642092Baiocchi G, Andrade CEMC, Ribeiro R, Moretti-Marques R, Tsunoda AT, Alvarenga-Bezerra V, Lopes A, Costa RLR, Kumagai LY, Badiglian-Filho L, Faloppa CC, Mantoan H, De Brot L, Dos Reis R, Goncalves BT. Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy in endometrial cancer: an open-label, non-inferiority, randomized trial (ALICE trial). Int J Gynecol Cancer. 2022 May 3;32(5):676-679. doi: 10.1136/ijgc-2022-003378.
PubMed 35236752
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Mapping Versus Sentinel Node Mapping With Systematic Lymphadenectomy in High Risk Endometrial Cancer: a Open Label, Non-inferiority, Randomized Trial.
- ClinicalTrials.gov ID
- NCT03366051
- Acronym / sponsor ID
- ALICE / 2.392.088
- Conditions
- Endometrial Cancer, Lymph Node Metastases
- Keywords
- Endometrial Cancer, Sentinel Lymph Node, Lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 8 Dec 2017 (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 will evaluate the role of systematic lymphadenectomy after sentinel node (SLN) mapping in high risk endometrial cancer (high grade histologies or deep myometrial invasion). The participants will be randomized in a non-inferiority controlled trial in 2 groups: SLN mapping or SLN mapping followed by systematic lymphadenectomy.
Detailed description
Although most patients with endometrial cancer present with early-stage disease, the standard treatment still includes systematic lymph node dissection for staging. Recently, SLN mapping has emerged as an acceptable surgical strategy when deciding between complete lymphadenectomy and no node dissection. This approach can help avoid the morbidity that is associated with a complete lymphadenectomy, such as neurovascular injury, lymphocyst formation, and lymphedema. A recent meta-analysis that included 55 studies and 4915 patients reported an overall SLN detection rate of 81% versus 50% for bilateral SLNs. Moreover, the use of indocyanine green increased the bilateral SLN detection rate compared with blue dye (74.6% vs. 50.5%). Yet, the studies noted an overall sensitivity of 96% and false negative rates of less than 5% when analyzed per hemipelvis. Since 2014, the National Comprehensive Cancer Network (NCCN) guidelines have recommended SLN mapping as an alternative option for node staging in endometrial cancer. However, most studies on SLN mapping have included patients who are at low risk for lymph node involvement and thus might underestimate the false negative rate. Recently, Soliman et al. reported a series of only high-grade and deep invasive endometrial cancers for which patients underwent SLN mapping, followed by pelvic and para-aortic lymph node dissection. An 89% detection rate was reported, suggesting that SLN mapping accurately identifies node metastases, with an negative predictive value (NPV) of 98% and an false negative predictive value (FNPV) of 2% when analyzed by hemipelvises. Positive nodes were found in 22.8% of patients (43% of isolated tumor cells and micrometastases), and in 40% of cases, the SLN was the only positive node. Data from the investigators corroborate these findings-26.7% of high-risk cases had positive nodes (50% of isolated tumor cells and micrometastases), and when analyzed by hemipelvis, the NPV was 97.9% and the FNPV was 2.1%. In 14 (70%) patients, the SLN was the only positive node. Moreover, there are few publications that have compared the results of the addition of SLN mapping to lymphadenectomy alone. Raimond et al. compared 156 patients that had SLN mapping with 95 who had pelvic node dissection. In their study, SLN mapping and imuno-histochemistry (IHC) were performed in low- and intermediate-risk patients, and the former detected metastatic node 3 times more often than complete pelvic lymphadenectomy alone (16.2% vs. 5.1%, p=0.03). They had no false negatives, and the IHC findings modified the adjuvant therapy in half of all cases. Holloway et al. compared a series of 661 patients who had undergone pelvic and para-aortic lymphadenectomy with 119 who were subjected to SLN mapping plus node dissection, including 68 high-intermediate- and high-risk patients in the SLN mapping group (GOG99 stratification). Despite the similarity in demographics and pathological risk factors, the SLN group had more LN metastases that were detected (30.3% vs. 16.3%; p<0.001) and received more adjuvant therapy (28.6% vs. 16.3%; p=0.003). The SLN was the only positive node in 18 (50%) of mapped cases, and the false negative rate was 2.8%.The investigators recently published a series on high risk endometrial cancer and also recorded a higher pelvic node metastasis rate for the SLN mapping group (26.7% vs. 14.3%, p=0.02) but no significant difference in para-aortic node metastases (13.5% vs. 5.6%, p=0.12). Notably, if considered only patients in whom SLNs were mapped, 31.3% had pelvic positive nodes. Despite the differences in uterine risk factors between groups, 10.6% (8/75) of patients in the SLN group had node metastasis that was diagnosed only after IHC. Excluding these patients, the SLN group would have had a node positivity rate of 17.3%, similar to the N-SLN group (17.4%), reinforcing the impact of IHC in the detection of node metastases. Moreover, the SLN group received more adjuvant chemotherapy (33.5% vs. 48%). The overall detection rate for SLNs was 85.3%, and bilateral SLNs were observed in 60%. The investigators noted an overall sensitivity of 90%, a negative predictive value of 95.7%, and a false negative predictive value of 4.3%. Recently, Touhami et al. showed that the risk of non-SLN metastasis is 61% when the SLN metastasis size is ≥2mm, and 5% for SLN metastasis of <2mm. However, one of the remaining uncertainties is the role of systematic lymphadenectomy after a positive SLN. In other words, is there any benefit in favor of systematic lymphadenectomy in a patient that already undergo adjuvant chemotherapy? The investigators hypothesized that there is no disease free survival benefit in adding systematic lymphadenectomy to only sentinel node mapping and proposed a prospective randomized controlled non-inferiority trial comparing SLN mapping to SLN mapping with systematic lymphadenectomy in high risk endometrial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Non-Inferiority Trial
| Arm | Type | Receives |
|---|---|---|
| Sentinel Node Mapping plus Lymphadenectomy | Active comparator | Procedure: Sentinel Node Mapping, Procedure: LymphadenectomyPatients with high risk endometrial cancer will undergo Sentinel Node Mapping followed by Systematic Pelvic and Para-Aortic Lymphadenectomy |
| Sentinel Node Mapping | Experimental | Procedure: Sentinel Node MappingPatients with high risk endometrial cancer will undergo Sentinel Node Mapping per NCCN algorithm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- High grade histologies (endometrioid grade 3, serous, clear cell and carcinosarcoma)
- Endometrioid grades 1 or 2 with myometrial invasion of ≥50%
- Endometrioid grades 1 or 2 with cervical invasion
- Clinically suitable to receive systematic lymphadenectomy
- Consent statement
Key exclusion criteria (3 listed)
- Previous hysterectomy in other institution
- Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis)
- Previous pelvic node dissection
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 Node MappingAt least one sentinel node should be retrieved in both hemipelvis. If no sentinel node is found in one hemipelvis, a side specific lymphadenectomy will be performed. | Procedure or surgery | Sentinel Node Mapping, Sentinel Node Mapping plus Lymphadenectomy |
| LymphadenectomySystematic Pelvic and Para-Aortic Lymphadenectomy | Procedure or surgery | Sentinel Node Mapping plus Lymphadenectomy |
Primary outcome
Recurrence
Time frame: 3 years
Recurrence Free Survival
5 secondary outcomes
Survival
Time frame: 5 years
Early morbidity
Time frame: <30 days after surgery
Late morbidity
Time frame: >30 days after surgery
Lymphedema
Time frame: Evaluation before surgery and after 6 and 12 months of follow-up
Quality of Life Questionary (QLQ)
Time frame: Evaluation before surgery and after 1 and 6 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 29058141Baiocchi G, Mantoan H, Kumagai LY, Goncalves BT, Badiglian-Filho L, de Oliveira Menezes AN, Faloppa CC, De Brot L, da Costa AABA. The Impact of Sentinel Node-Mapping in Staging High-Risk Endometrial Cancer. Ann Surg Oncol. 2017 Dec;24(13):3981-3987. doi: 10.1245/s10434-017-6132-8. Epub 2017 Oct 20.
- Background: PubMed 28566221Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.
- Background: PubMed 26905211Holloway RW, Gupta S, Stavitzski NM, Zhu X, Takimoto EL, Gubbi A, Bigsby GE, Brudie LA, Kendrick JE, Ahmad S. Sentinel lymph node mapping with staging lymphadenectomy for patients with endometrial cancer increases the detection of metastasis. Gynecol Oncol. 2016 May;141(2):206-210. doi: 10.1016/j.ygyno.2016.02.018. Epub 2016 Mar 2.
- Background: PubMed 28528918Soliman PT, Westin SN, Dioun S, Sun CC, Euscher E, Munsell MF, Fleming ND, Levenback C, Frumovitz M, Ramirez PT, Lu KH. A prospective validation study of sentinel lymph node mapping for high-risk endometrial cancer. Gynecol Oncol. 2017 Aug;146(2):234-239. doi: 10.1016/j.ygyno.2017.05.016. Epub 2017 May 18.
- Background: PubMed 28159465Rossi EC, Kowalski LD, Scalici J, Cantrell L, Schuler K, Hanna RK, Method M, Ade M, Ivanova A, Boggess JF. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol. 2017 Mar;18(3):384-392. doi: 10.1016/S1470-2045(17)30068-2. Epub 2017 Feb 1.
- Background: PubMed 27871836Bodurtha Smith AJ, Fader AN, Tanner EJ. Sentinel lymph node assessment in endometrial cancer: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 May;216(5):459-476.e10. doi: 10.1016/j.ajog.2016.11.1033. Epub 2016 Nov 18.
- Background: PubMed 24586087Abu-Rustum NR. Sentinel lymph node mapping for endometrial cancer: a modern approach to surgical staging. J Natl Compr Canc Netw. 2014 Feb;12(2):288-97. doi: 10.6004/jnccn.2014.0026.
- Background: PubMed 24642092Raimond E, Ballester M, Hudry D, Bendifallah S, Darai E, Graesslin O, Coutant C. Impact of sentinel lymph node biopsy on the therapeutic management of early-stage endometrial cancer: Results of a retrospective multicenter study. Gynecol Oncol. 2014 Jun;133(3):506-11. doi: 10.1016/j.ygyno.2014.03.019. Epub 2014 Mar 15.
- Derived from this study: PubMed 35236752Baiocchi G, Andrade CEMC, Ribeiro R, Moretti-Marques R, Tsunoda AT, Alvarenga-Bezerra V, Lopes A, Costa RLR, Kumagai LY, Badiglian-Filho L, Faloppa CC, Mantoan H, De Brot L, Dos Reis R, Goncalves BT. Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy in endometrial cancer: an open-label, non-inferiority, randomized trial (ALICE trial). Int J Gynecol Cancer. 2022 May 3;32(5):676-679. doi: 10.1136/ijgc-2022-003378.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Glauco Baiocchi, MD, PhD principal investigator
Department of Gynecologic Oncology - AC Camargo Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Node Mapping and Lymphadenectomy in people with Endometrial Cancer and Lymph Node Metastases, run by AC Camargo Cancer Center at 5 sites in Brazil.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruna Goncalves, RN, MSc (551121895110, bruna.goncalves@accamargo.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 3 years). 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 NCT03366051, which also lists 9 linked publications.
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 30 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.