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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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Region Oestergoetland Linkoping Sweden

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
Norrlands University Hospital Umea Sweden
Svtxkvsxbcl Uxwcynnkfd Hfkynspldhjptub Gdfawecdueqpngjyt Gothenburg Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not recruiting
01.09.2023

Trial locations

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.

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 ID:
2023-505991-31-00
Protocol code:
BIOMEC trial
Trial Phase:
Therapeutic confirmatory (Phase III)

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