Clinical trial NCT03677024: Evaluation of the Efficacy for Sentinel Lymph Node Policy in Intermediate-risk Endometrial Carcinomas
Official title: Evaluation of the Efficacy for Sentinel Lymph Node Policy in Intermediate-risk Endometrial Carcinomas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endometrial Endometrioid Adenocarcinoma
Keywords: Sentinel lymph node policy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas

Detailed description: Surgical assessment for staging of endometrial carcinoma during primary surgery remains one of the most varied practices worldwide, as it may include no nodal assessment, sentinel node mapping, and complete pelvic and aortic lymphadenectomy up to the renal vessels. Since lymphadenectomy is significantly associated with longer operating time, higher surgical costs, greater rate of infection, as well as the occurrence of lymphocysts and lymphedema, gynecologists agree that pelvic and aortic lymphadenectomy should be routinely performed in high-risk patients (grade 3, deep myometrial invasion, type 2 cancer). However, whether lymphadenectomy is required in patients with endometrioid endometrial cancers of grade 1 or 2 and with less than 50% myometrial invasion is controversial. Then, the investigators conducted this prospective cohort study to investigate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas (grade 1 or 2, \< 50% myometrial invasion, and a tumor diameter ≥ 2 cm) as well as their outcomes.

Surgery should be performed within a maximum of 4 weeks from the patient's first consultation.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. No contraindication to surgery.
3. Signed and dated informed consent.
4. Intermediate-risk endometrioid cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations).
5. Without any suspicious pelvic, paraaortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/PET-CT.

Exclusion Criteria:

1. Low-risk endometrioid cancer with grade 1-2, superficial myometrial invasion and tumor diameter \< 2cm (in intraoperative frozen section examinations).
2. Grade 3 endometrioid cancer (in preoperative pathological diagnosis or in intraoperative frozen section examinations).
3. Deep muscular infiltration (in intraoperative frozen section examinations).
4. Cervical invasion and/or ovarian/tubal invasion (in intraoperative frozen section examinations).
5. With suspicious pelvic, paraaortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/PET-CT.

Primary outcomes:
measure: Performance Analysis
timeFrame: Within 14 days after the surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: 1 years after the surgery
measure: Recurrence rate
timeFrame: 5 years after the surgery
measure: Adjuvant therapy rate
timeFrame: 5 years after the surgery
measure: 5-year survival rate
timeFrame: 5 years after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Obstetrics and Gynecology Hospital, Fudan University
name: Xiaojun Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu M, Jia N, Huang F, Liu X, Zhao Y, Tao X, Jiang W, Li Q, Feng W. Whether intermediate-risk stage 1A, grade 1/2, endometrioid endometrial cancer patients with lesions larger than 2 cm warrant lymph node dissection? BMC Cancer. 2017 Oct 23;17(1):696. doi: 10.1186/s12885-017-3671-0.
citation: Yang B, Shan B, Xue X, Wang H, Shan W, Ning C, Zhou Q, Chen X, Luo X. Predicting Lymph Node Metastasis in Endometrial Cancer Using Serum CA125 Combined with Immunohistochemical Markers PR and Ki67, and a Comparison with Other Prediction Models. PLoS One. 2016 May 10;11(5):e0155145. doi: 10.1371/journal.pone.0155145. eCollection 2016.
citation: How J, Lau S, Press J, Ferenczy A, Pelmus M, Stern J, Probst S, Brin S, Drummond N, Gotlieb W. Accuracy of sentinel lymph node detection following intra-operative cervical injection for endometrial cancer: a prospective study. Gynecol Oncol. 2012 Nov;127(2):332-7. doi: 10.1016/j.ygyno.2012.08.018. Epub 2012 Aug 19.
citation: Barlin JN, Khoury-Collado F, Kim CH, Leitao MM Jr, Chi DS, Sonoda Y, Alektiar K, DeLair DF, Barakat RR, Abu-Rustum NR. The importance of applying a sentinel lymph node mapping algorithm in endometrial cancer staging: beyond removal of blue nodes. Gynecol Oncol. 2012 Jun;125(3):531-5. doi: 10.1016/j.ygyno.2012.02.021. Epub 2012 Feb 22.
citation: Vidal F, Leguevaque P, Motton S, Delotte J, Ferron G, Querleu D, Rafii A. Evaluation of the sentinel lymph node algorithm with blue dye labeling for early-stage endometrial cancer in a multicentric setting. Int J Gynecol Cancer. 2013 Sep;23(7):1237-43. doi: 10.1097/IGC.0b013e31829b1b98.
citation: Ballester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12.