Sentinel Node Mapping in High Risk Endometrial Cancer

NCT03366051RecruitingNAINTERVENTIONAL

Summary

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

Sentinel Node Mapping in High Risk Endometrial Cancer