Sentinel Node Mapping in High Risk Endometrial Cancer

NCT03366051 | Recruiting DMC

• 1 other identifier: 2.392.088
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 5

Brief 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). The participants will be randomized in a non-inferiority controlled trial in 2 groups: SLN mapping or SLN mapping followed by systematic lymphadenectomy.

Conditions

Endometrial Cancer; Lymph Node Metastases

Keywords

Endometrial Cancer; Sentinel Lymph Node; Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• Recurrence

  Recurrence Free Survival

  3 years

Secondary Outcomes (5)

• Survival

  5 years

• Early morbidity

  <30 days after surgery

• Late morbidity

  >30 days after surgery

• Lymphedema

  Evaluation before surgery and after 6 and 12 months of follow-up

• Quality of Life Questionary (QLQ)

  Evaluation before surgery and after 1 and 6 months of follow-up

Study Arms (2)

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

Procedure: Sentinel Node Mapping; Procedure: Lymphadenectomy

Sentinel Node Mapping

EXPERIMENTAL

Patients with high risk endometrial cancer will undergo Sentinel Node Mapping per NCCN algorithm

Procedure: Sentinel Node Mapping

Interventions

Sentinel Node Mapping PROCEDURE

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.

Sentinel Node Mapping; Sentinel Node Mapping plus Lymphadenectomy

Lymphadenectomy PROCEDURE

Systematic Pelvic and Para-Aortic Lymphadenectomy

Sentinel Node Mapping plus Lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous hysterectomy in other institution
• Presence of extra-uterine disease (peritoneal, visceral or suspicious lymph node metastasis)
• Previous pelvic node dissection

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (5)

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

RECRUITING

Hospital do Cancer de Barretos

Barretos, São Paulo, Brazil

RECRUITING

AC Camargo Cancer Center

São Paulo, São Paulo, 01509010, Brazil

RECRUITING

Albert Einstein Hospital

São Paulo, São Paulo, Brazil

RECRUITING

Sao Camilo Oncologia

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (9)

• 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.

  PMID: 29058141 BACKGROUND

• Holloway 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.

  PMID: 28566221 BACKGROUND

• Holloway 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.

  PMID: 26905211 BACKGROUND

• Soliman 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.

  PMID: 28528918 BACKGROUND

• Rossi 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.

  PMID: 28159465 BACKGROUND

• Bodurtha 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.

  PMID: 27871836 BACKGROUND

• Abu-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.

  PMID: 24586087 BACKGROUND

• Raimond 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.

  PMID: 24642092 BACKGROUND

• Baiocchi 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.

  PMID: 35236752 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms; Lymphatic Metastasis

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Glauco Baiocchi, MD, PhD

  Department of Gynecologic Oncology - AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruna Goncalves, RN, MSc

CONTACT

551121895110; bruna.goncalves@accamargo.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Gynecologic Oncology

Model Details: Randomized Controlled Non-Inferiority Trial

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: December 22, 2017
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (5)