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Sentinel Node Mapping in High Risk Endometrial Cancer

NCT03366051RecruitingNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

AC Camargo Cancer Center

Enrollment

178

Start Date

2017-12-22

Completion Date

2024-12-20

Study Type

INTERVENTIONAL

Official Title

Sentinel Node Mapping Versus Sentinel Node Mapping With Systematic Lymphadenectomy in High Risk Endometrial Cancer: a Open Label, Non-inferiority, Randomized Trial.

Interventions

Sentinel Node MappingLymphadenectomy

Conditions

Endometrial CancerLymph Node Metastases

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

Inclusion Criteria:

* 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

Exclusion Criteria:

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

Outcome Measures

Primary Outcomes

Recurrence

Recurrence Free Survival

Time frame: 3 years

Secondary Outcomes

Survival

Overall Survival

Time frame: 5 years

Early morbidity

Surgical and clinical morbidity

Time frame: <30 days after surgery

Late morbidity

Surgical and clinical morbidity

Time frame: >30 days after surgery

Lymphedema

Presence and lymphedema graduation

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

Quality of Life Questionary (QLQ)

EORTC QLQ-C30

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

Locations

Hospital Erasto Gaertner, Curitiba, Brazil

Hospital do Cancer de Barretos, Barretos, Brazil

AC Camargo Cancer Center, São Paulo, Brazil

Albert Einstein Hospital, São Paulo, Brazil

Sao Camilo Oncologia, São Paulo, Brazil

Linked Papers

2022-05-03

Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy in endometrial cancer: an open-label, non-inferiority, randomized trial (ALICE trial)

Growing evidence suggest that sentinel lymph node (SLN) biopsy in endometrial cancer accurately detects lymph node metastasis. However, prospective randomized trials addressing the oncological outcomes of SLN biopsy in endometrial cancer without lymphadenectomy are lacking. The present study aims to confirm that SLN biopsy without systematic node dissection does not negatively impact oncological outcomes. We hypothesized that there is no survival benefit in adding systematic lymphadenectomy to sentinel node mapping for endometrial cancer staging. Additionally, we aim to evaluate morbidity and impact in quality of life (QoL) after forgoing systematic lymphadenectomy. This is a collaborative, multicenter, open-label, non-inferiority, randomized trial. After total hysterectomy, bilateral salpingo-oophorectomy and SLN biopsy, patients will be randomized (1:1) into: (a) no further lymph node dissection or (b) systematic pelvic and para-aortic lymphadenectomy. Inclusion criteria are patients with high-grade histologies (endometrioid G3, serous, clear cell, and carcinosarcoma), endometrioid G1 or G2 with imaging concerning for myometrial invasion of ≥50% or cervical invasion, clinically suitable to undergo systematic lymphadenectomy. The primary objective is to compare 3-year disease-free survival and the secondary objectives are 5-year overall survival, morbidity, incidence of lower limb lymphedema, and QoL after SLN mapping ± systematic lymphadenectomy in high-intermediate and high-risk endometrial cancer. 178 participants will be randomized in this study with an estimated date for completing accrual of December 2024 and presenting results in 2027. NCT03366051.

Linked Investigators

Andre Lopes

Glauco Baiocchi

Levon Badiglian-Filho

Reitan Ribeiro

Ricardo dos Reis

PhD, Professor, MD Hospital de Câncer de Barretos. Gynecologic Oncology Department