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Endometrial Endometrioid AdenocarcinomaNCT03677024

Evaluation of the Efficacy for Sentinel Lymph Node Policy in Intermediate-risk Endometrial Carcinomas

A study testing SLN arm in people with Endometrial Endometrioid Adenocarcinoma, run by Fudan University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To evaluate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas Read more about this study

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Endometrial Endometrioid Adenocarcinoma
What is being tested?
SLN arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
6 Feb 2020to 7 Oct 2021
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 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Obstetrics and Gynecology Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

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

Read the 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.

Being tested
SLN arm
Keywords
Sentinel lymph node policy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLN armProcedure or surgery

    Intra-operative SN mapping with indocyanin green: Intracervical injection will be performed by the surgeon. Sub-mucous injections will be performed with 50% diluted dye at 3 and 9 o'clock positions. 1ml injection contained infracyanine green will be injected deeply into the stroma of the cervix (1cm-depth), and another 1ml will be injected superficially (2mm-depth). The time between the injection and the search for SLN must be as soon as possible.

Study groups in NCT03677024
Study groupRoleWhat they receive
SLN armExperimentalExperimental: 1. Intra-operative sentinel lymph node (SLN) mapping with indocyanin green injected into the stroma of the cervix. 2. Full bilateral laparoscopic lymphadenectomy and hysterectomy: If bilateral SLN are detected, all positive SLN will be removed. Then the surgeons proceeds to a total hysterectomy. If only unilateral SLN are detected, surgeons will proceed to pelvic lymphadenectomy on the opposite side. If non SLN are detected, surgeons will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic lymphadenectomy.
Receives: Procedure: SLN arm
Lymphadenectomy armNo interventionSurgeons will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic lymphadenectomy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance Analysis

    Using the final pathological diagnosis as the Gold Standard, the investigators will calculate the sensitivity, specificity, and predictive accuracy of mapping and detection of SLN with metastatic disease.

    Measured: Within 14 days after the surgery

Secondary outcomes (4)

  1. Postoperative complications

    Comparison of the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc.

    Measured: 1 years after the surgery

  2. Recurrence rate

    The recurrence rate of different groups will be followed up.

    Measured: 5 years after the surgery

  3. Adjuvant therapy rate

    The adjuvant therapy rate of different groups will be followed up.

    Measured: 5 years after the surgery

  4. 5-year survival rate

    The 5-year survival rate of different groups will be followed up.

    Measured: 5 years after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2018
  2. Study start6 Feb 2020
  3. Primary completion7 Oct 2021
  4. Study completion7 Oct 2021

Why it stopped: This study was not approved by the Ethics Committee

Resources

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
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03677024
Sponsor's protocol ID
53201012
Status last verified
Sep 2024
First submitted
13 Sep 2018
Last updated
26 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29061125

  • 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.

    PubMed 27163153

  • 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.

    PubMed 22910695

  • 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.

    PubMed 22366409

  • 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.

    PubMed 23839245

  • 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.

    PubMed 21489874

Questions about this trial

What is this clinical trial studying?

A study testing SLN arm in people with Endometrial Endometrioid Adenocarcinoma, run by Fudan University at 1 site in China.

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 5 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: withdrawn, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance Analysis (time frame: Within 14 days after the surgery). 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 NCT03677024, which also lists 6 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 26 Sep 2024.

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