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Study Comparing Sentinel Node Policy with Current Staging Protocols in Early Stage Endometrial Cancer Using Patent Blue, Technetium (99mTc) Rheniumsulfide, and Indocyanine Green

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying early-stage endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study is particularly interested in cases that are at intermediate and high risk of coming back after treatment. The trial will compare two different approaches to checking the spread of cancer to the lymph nodes. One approach is the sentinel node policy, which involves removing only a few key lymph nodes, and the other is the current standard practice in France, which may involve removing more lymph nodes.

Participants in the study will receive one of several treatments, which include Patent Blue, Technetium (99mTc) Rheniumsulfide Colloid, Indocyanine Green, and Technetium (99mTc) Nanocolloid. These substances are used to help identify the lymph nodes that need to be examined. The study will look at how these treatments affect the body during and after surgery, focusing on any complications that might occur. The goal is to see if the sentinel node policy can reduce the risk of complications compared to the standard approach.

The trial will follow participants for up to three years after their surgery to monitor for any complications and to see how well the cancer is controlled. This includes checking for any signs of the cancer returning and assessing the overall health and survival of the participants. The study aims to provide valuable information that could improve the way early-stage endometrial cancer is treated in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient is required to provide signed and dated informed consent. This confirms understanding and agreement to participate in the trial.
Step 2
Initial assessment
The patient undergoes an initial assessment to confirm eligibility. This includes a clinical examination, imaging tests such as MRI or CT scan, and an endometrial biopsy or curettage. The purpose is to determine the stage and risk level of the endometrial cancer.
Step 3
Randomization
The patient is randomly assigned to one of two groups: the sentinel node (SN) policy group or the standard surgical staging group. This determines the type of surgical procedure the patient will undergo.
Step 4
Surgical procedure
In the SN policy group, the procedure involves the removal of sentinel nodes, which are the first lymph nodes to which cancer cells are likely to spread. If these nodes are negative, a complete pelvic lymphadenectomy may not be necessary.
In the standard group, a full lymphadenectomy is performed, which may include pelvic and paraaortic lymph nodes, depending on the risk stratification.
Step 5
Post-operative assessment
After surgery, the patient is monitored for any complications related to the procedure. This includes checking for issues such as blood loss, urinary or digestive problems, and nerve-related disorders.
The assessment continues up to 30 days post-surgery, with complications being scored according to a standardized scale.
Step 6
Follow-up
The patient is followed up for up to three years post-surgery to monitor for any long-term complications or recurrence of cancer. This includes regular check-ups and imaging tests as needed.

Who can join the trial?

11 criteria

Patients must have early endometrial carcinoma, which is a type of cancer that starts in the lining of the uterus.
The cancer should be in an early stage, specifically FIGO clinical stage I-II. FIGO is a system used to describe how much cancer has spread.
Patients should be classified into specific risk groups based on guidelines. These groups are intermediate-risk endometrioid, high-risk endometrioid, or high-risk non-endometrioid.
There should be no suspicious lymph nodes detected in imaging tests like MRI or CT scans before surgery.
Patients must be 18 years of age or older.
Patients should have a performance status of 2 or less. This is a measure of how well a patient can perform ordinary tasks.
There should be no medical reasons preventing the patient from having surgery.
Patients must not have known allergies to certain substances used in the study, such as specific dyes or compounds.
Patients need to provide signed and dated informed consent, which means they agree to participate after understanding the study details.
Patients with the potential to become pregnant must use effective birth control.
Patients must be part of a health insurance system.

Who cannot join the trial?

3 criteria

Patients who are not female cannot participate in the study.
Patients who do not have intermediate-risk or high-risk endometrial cancer cannot participate.
Patients who are not considered part of a vulnerable population cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Besancon University Hospital Center
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Besançon, France
Centr Georges Francois Leclerc
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Dijon, France
Centre Hospitalier Et Universitaire De Limoges
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Limoges, France

Trial locations

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Investigated drugs

SENTIRAD-1502: This is a clinical trial that involves a surgical procedure called sentinel node policy. In this trial, the sentinel node policy is compared to the current French initial staging protocols for early-stage endometrial carcinomas that are at intermediate and high risk of recurrence. The sentinel node policy involves the removal of only the sentinel lymph nodes, which are the first few lymph nodes into which a tumor drains. This approach may be followed by a complete pelvic lymphadenectomy if the sentinel nodes are negative for cancer. The goal is to assess the morbidity, or complications, related to lymph node dissection in comparison to more extensive surgical staging protocols.

What is already known about the treatment

SENTIRAD-1502 – This medication is currently being studied in a clinical trial for its effectiveness in treating intermediate-risk and high-risk endometrial cancer. The trial aims to compare the outcomes of using a sentinel node policy versus traditional surgical staging protocols. The main therapeutic indication is for endometrial cancer, particularly in cases with a higher risk of recurrence. The mechanism of action involves the selective identification and removal of sentinel lymph nodes to potentially reduce surgical morbidity. SENTIRAD-1502 is classified under investigational treatments in oncology, focusing on surgical intervention strategies.

Investigated diseases

Endometrial Cancer – Endometrial cancer is a type of cancer that begins in the lining of the uterus, known as the endometrium. It is most commonly diagnosed in postmenopausal women, but it can occur before menopause as well. The disease often presents with abnormal vaginal bleeding, which prompts further investigation. As the cancer progresses, it may invade deeper layers of the uterus and spread to nearby organs or lymph nodes. Intermediate-risk and high-risk categories indicate a greater likelihood of the cancer spreading or recurring. The progression of the disease can vary, with some cases remaining localized while others may metastasize to distant sites.