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Study on the Effectiveness of Biomarker Staging Compared to Conventional Staging in Women with Early-Stage Endometrial Cancer Using Paclitaxel and Carboplatin

Verified siteRegistered drugNo placebo
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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 endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study aims to compare two different methods of staging the cancer: using biomarkers, which are substances that can be measured in the body to indicate the presence of cancer, and the conventional method, which is the standard way of assessing the cancer's stage. The purpose of the study is to determine if the biomarker method is as effective as the conventional method in selecting women for additional treatment after surgery.

Participants in the study will receive treatments that may include paclitaxel and carboplatin, which are medications used to treat cancer. These medications are given through an intravenous infusion, meaning they are delivered directly into the bloodstream through a vein. The study will also involve a comparison with a placebo, which is a substance with no active medication, to help understand the effectiveness of the treatments. The study will last for a period of up to 18 months, during which participants will be monitored for their overall survival and recurrence-free survival, which means the length of time they live without the cancer coming back.

Throughout the study, various assessments will be conducted to evaluate the participants' quality of life and any side effects they may experience. These assessments will include questionnaires and medical imaging tests. The study will also look at the cost-effectiveness of the treatments and any complications that may occur within 30 days after surgery. The goal is to gather information that could improve the way 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.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and diagnosis of endometrial cancer.

    Informed consent is required, ensuring understanding of the study procedures and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate overall health and suitability for the trial.

    This includes a review of medical history, physical examination, and necessary laboratory tests.

  3. Step 3

    Surgery

    Surgery is planned with the intent to cure the cancer.

    The procedure is performed based on the standard medical guidelines for endometrial cancer.

  4. Step 4

    Adjuvant treatment

    Following surgery, adjuvant treatment is administered to reduce the risk of cancer returning.

    This involves the use of paclitaxel and carboplatin, both given intravenously.

    The specific dosage and frequency are determined by the medical team based on individual patient needs.

  5. Step 5

    Follow-up assessments

    Regular follow-up assessments are scheduled to monitor health and response to treatment.

    These assessments include physical exams, imaging tests, and laboratory evaluations.

  6. Step 6

    Completion of trial

    The trial is estimated to conclude by September 28, 2029.

    Final assessments are conducted to evaluate overall survival and recurrence-free survival.

Who can join the trial?

14 criteria

  • Must have a primary cancer in the lining of the uterus, confirmed by a tissue test.
  • Must be a woman who can understand and follow the study procedures.
  • Must have a presumed early stage of cancer, specifically FIGO stage I-II. FIGO is a system used to describe the extent of cancer.
  • Must have planned surgery aimed at curing the cancer.
  • Must be a suitable candidate for surgery.
  • Must be a suitable candidate for additional treatment after surgery, known as adjuvant treatment.
  • Must have an ECOG performance status of 0-2. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Must have signed an approved Informed Consent, which means agreeing to participate after understanding the study details.
  • Must be 18 years of age or older.
  • Must have adequate organ function, which includes:
    • Haemoglobin level of at least 9.0 grams per deciliter (g/dL).
    • Absolute neutrophil count (ANC) of at least 1500 per microliter (μL). Neutrophils are a type of white blood cell important for fighting infections.
    • Platelet count of at least 100,000 per microliter (μL). Platelets help with blood clotting.
    • Creatinine level no more than 1.5 times the upper limit of normal (ULN). Creatinine is a waste product measured to check kidney function.
    • AST and ALT levels no more than 2.5 times the upper limit of normal (ULN). These are liver enzymes measured to check liver function.

Who cannot join the trial?

4 criteria

  • Patients who do not have a diagnosis of endometrial cancer cannot participate. Endometrial cancer is a type of cancer that starts in the lining of the uterus.
  • Only women can participate in this study. Men are not eligible.
  • Participants must be within a certain age range, typically adults and older adults. Specific age limits are not provided here.
  • Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not eligible.
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Investigated drugs

BIOMEC: This is a code name for a new approach being tested in the trial. It involves using specific biomarkers to stage endometrial cancer. The goal is to see if this method is as effective as the traditional way of staging the cancer. This could help doctors decide on the best treatment plan for women with early-stage endometrial cancer.

What is already known about the treatment

Biomarker Staging Therapy – This treatment is administered through a personalized approach based on specific biomarkers identified in patients with endometrial cancer. Currently, it is being evaluated in clinical trials to determine its effectiveness compared to traditional staging methods. The main therapeutic indication is for women with presumed early-stage endometrial cancer. The mechanism of action involves using molecular markers to guide treatment decisions, potentially improving outcomes by tailoring therapy to the individual's cancer profile. It falls under the pharmacological classification of targeted therapy, focusing on specific characteristics of cancer cells.

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 women who have gone through menopause. The disease often presents with symptoms such as abnormal vaginal bleeding or discharge. As it progresses, the cancer can invade the muscular layer of the uterus and may spread to nearby organs or lymph nodes. Early detection is crucial as it typically starts in the inner lining and can be more easily treated if caught before spreading. The progression of the disease can vary, with some cases remaining localized while others may advance more aggressively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505991-31-00Protocol codeBIOMEC trialEstimated enrolment1 037 patientsSponsorKarolinska University Hospital

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