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Study on Letrozole Maintenance Therapy for Patients with Epithelial Ovarian Cancer

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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 the effects of a medication called letrozole in patients with epithelial ovarian cancer. Epithelial ovarian cancer is a type of cancer that begins in the layer of cells covering the ovaries. The study aims to evaluate how effective letrozole is as a maintenance therapy after patients have undergone standard treatments, which typically include surgery and chemotherapy. Maintenance therapy is a treatment given to help keep cancer from coming back after it has responded to initial treatment.

Participants in the study will be randomly assigned to receive either letrozole or a placebo, which is a tablet that looks like the medication but does not contain any active ingredients. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving letrozole and who is receiving the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The main goal is to see if letrozole can help extend the time patients live without their cancer getting worse, known as progression-free survival.

The study will take place over a period of time, with participants taking the medication or placebo orally for up to 60 months. Throughout the study, participants will have regular check-ups to monitor their health and the status of their cancer. The researchers will also look at other outcomes, such as overall survival and quality of life, to understand the full impact of letrozole as a maintenance therapy for epithelial ovarian cancer.

The research process

The trial runs in 5 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, eligibility is confirmed based on specific criteria such as age, medical history, and previous treatments.
A negative pregnancy test is required for women of childbearing potential.
Informed consent is signed to acknowledge understanding of the study procedures.
Step 2
Randomization
Participants are randomly assigned to receive either the active medication, letrozole, or a placebo.
This process ensures that the study is double-blinded, meaning neither the participants nor the researchers know who receives the active medication.
Step 3
Medication administration
The active medication, letrozole, is administered orally in the form of 2.5 mg film-coated tablets.
The medication is taken daily as part of the maintenance therapy for epithelial ovarian cancer.
Step 4
Monitoring and follow-up
Regular visits are scheduled to monitor health status and any side effects.
Progression-Free Survival (PFS) is measured to evaluate the effectiveness of the treatment.
Additional assessments include Overall Survival (OS) and Quality-Adjusted Progression Free Survival (QAPFS).
Step 5
Completion of the study
The study is estimated to conclude by June 30, 2037.
Final evaluations are conducted to assess the long-term outcomes of the treatment.

Who can join the trial?

10 criteria

Patients must be **18 years of age or older**.
Women who can have children must have a **negative pregnancy test** before starting the study treatment.
Patients must be **willing and able** to attend all study visits and understand the procedures involved.
Patients must have a **newly diagnosed** type of cancer called **epithelial ovarian, fallopian tube, or peritoneal cancer**, confirmed by a lab test, and be in **FIGO Stage II to IV**. FIGO stages describe how much the cancer has spread.
Patients must have had a surgery called **(interval-) debulking**, which is done to remove as much of the tumor as possible.
Patients must have an **ECOG-Performance Status of 0-2**. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
Patients must have **signed informed consent forms** to participate in the study.
Patients must have **paraffin-embedded tissue or cell samples** available. These are samples of the tumor preserved for testing.
Patients must have a **positivity of 1% or more for ER expression**. ER expression refers to the presence of estrogen receptors in the cancer cells, which is determined by a specific lab test.
Patients must have received **at least 4 cycles of platinum-based chemotherapy**. This is a type of cancer treatment that uses drugs containing platinum to kill cancer cells. Neoadjuvant chemotherapy, which is given before surgery, is allowed.

Who cannot join the trial?

4 criteria

Patients who do not have epithelial ovarian cancer cannot participate. This type of cancer affects the surface layer of the ovaries.
Only female patients are eligible for this study.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
Patients who are considered part of a vulnerable population are not eligible. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.

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Verified sites

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

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany

Trial locations

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Investigated drugs

Letrozole is a medication used in this clinical trial as a maintenance therapy for patients with epithelial ovarian cancer. It is an aromatase inhibitor, which means it works by reducing the amount of estrogen in the body. This can help slow down or stop the growth of certain types of cancer cells that need estrogen to grow. The trial aims to evaluate the effectiveness of letrozole in extending the time patients live without their cancer getting worse after they have received standard surgical and chemotherapy treatments.

Letrozole

What is already known about the treatment

Letrozole – Letrozole is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness as a maintenance therapy in epithelial ovarian cancer. The main therapeutic indication for letrozole is to help prevent the progression of cancer after initial treatment with surgery and chemotherapy. At the molecular level, letrozole works by inhibiting the enzyme aromatase, which reduces estrogen production, a hormone that can promote the growth of certain cancer cells. It is classified as an aromatase inhibitor in pharmacology.

Investigated diseases

Epithelial Ovarian Cancer – Epithelial ovarian cancer is a type of cancer that begins in the layer of cells covering the ovaries. It is the most common form of ovarian cancer and typically affects women after menopause. The disease often goes undetected until it has spread within the pelvis and abdomen, making it more challenging to treat. Symptoms can be vague and may include bloating, pelvic pain, and changes in bowel habits. As the cancer progresses, it can spread to other parts of the body, including the lining of the abdomen and the lymph nodes. Early detection is difficult, and the disease is often diagnosed at an advanced stage.