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Study on Olaparib for Patients with p53abn Endometrial Cancer After Chemoradiation Therapy

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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 a type of cancer known as endometrial cancer, specifically a subtype called p53abn endometrial cancer. The trial is investigating the effects of a medication called olaparib, which is taken in the form of film-coated tablets. Olaparib is being tested to see if it can help prevent the cancer from coming back after patients have already received a combination of chemotherapy and radiation therapy, known as chemoradiation.

The purpose of the study is to determine if taking olaparib as a maintenance therapy can improve the time patients remain free from cancer recurrence compared to just being observed without additional treatment. Participants in the study will be randomly assigned to either receive olaparib or be placed under observation. The study will last for a period of up to 24 months, during which participants will be monitored regularly to assess their health and any changes in their condition.

Endometrial cancer is a type of cancer that begins in the lining of the uterus. The trial is specifically for patients who have undergone surgery to remove the cancer and have no signs of the disease remaining. The study aims to provide valuable information on whether olaparib can be an effective treatment option to help prevent the return of this specific type of cancer. Participants will be closely followed by healthcare professionals throughout the study to ensure their safety and well-being.

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, the patient will be randomly assigned to one of two groups: one receiving olaparib and the other under observation.
The purpose of this assignment is to compare the effects of olaparib with observation after chemoradiotherapy in patients with a specific type of endometrial cancer.
Step 2
Medication administration
Patients in the olaparib group will take the medication orally. The available dosages are 150 mg and 100 mg film-coated tablets.
The exact dosage and frequency will be determined by the study protocol and the patient's specific needs.
Step 3
Treatment duration
The treatment with olaparib will continue for a specified period, as outlined in the study protocol.
Patients will be monitored regularly to assess the effectiveness and any side effects of the treatment.
Step 4
Observation period
Patients in the observation group will not receive olaparib but will be closely monitored for any signs of cancer recurrence.
Regular check-ups will be scheduled to ensure the patient's health and to gather data for the study.
Step 5
Follow-up
After the treatment or observation period, patients will continue to be followed up to monitor their health status.
The follow-up will help determine the long-term effects of the treatment and the overall survival rates.

Who can join the trial?

19 criteria

Must have a confirmed diagnosis of endometrial cancer (EC), which is a type of cancer that starts in the lining of the uterus. This includes various subtypes like endometrioid, serous, clear cell, undifferentiated carcinomas, and uterine carcinosarcoma.
Must have a WHO Performance score of 0-1, which means the patient is fully active or has some symptoms but can still carry out light work.
Must have Stage I to III EC with myometrial invasion, meaning the cancer has spread into the muscle layer of the uterus.
Must have a specific molecular classification called p53abn EC.
Body weight must be more than 30 kg (about 66 pounds).
Must have normal organ and bone marrow function, which includes:
- Creatinine clearance greater than 50 cc/min, indicating good kidney function.
- Hemoglobin level of at least 10.0 g/dl without recent blood transfusions, indicating healthy red blood cells.
- Absolute neutrophil count (ANC) of at least 1.5 x 10⁹/l, indicating a healthy immune system.
- Platelet count of at least 100 x 10⁹/l, indicating good blood clotting ability.
- Liver function tests within normal limits, unless the patient has a condition called Gilbert's syndrome.
- Molecular classification must be done according to a specific diagnostic method, ensuring certain genetic markers are present.
- Must understand and sign a written informed consent form before any study procedures begin, showing they agree to participate.
- Must be part of a social security system or have similar benefits.
- Must have had surgery to remove the uterus and ovaries, with or without additional procedures, and no visible cancer left after surgery.
- No signs of cancer spread to distant parts of the body, confirmed by imaging tests like CT or PET scans.
- Must be at least 18 years old.
- Must have a life expectancy of at least 16 weeks.
- Must be able to attend treatment sessions and follow-up visits.
- Must provide written informed consent for participation in related research projects.

Who cannot join the trial?

7 criteria

Patients who have not been diagnosed with p53abn HREC. This is a specific type of cancer diagnosis.
Patients who have not been treated with the intent to cure the cancer.
Patients who have not undergone surgery, specifically a hysterectomy (removal of the uterus) and bilateral salpingo-oophorectomy (removal of both ovaries and fallopian tubes).
Patients who have signs of remaining cancer or cancer that has spread to other parts of the body.
Patients who are male, as the study is only for female subjects.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population that is not selected for this study.

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Verified sites

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

Assistance Publique Hopitaux De Paris
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Paris, France
Assistance Publique Hopitaux De Paris
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Paris, France
Besancon University Hospital Center
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Besançon, France

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Investigated drugs

Olaparib is a medication being tested in this clinical trial. It is used as a maintenance therapy to see if it can improve the time patients remain free from cancer recurrence after they have received chemoradiotherapy for a specific type of endometrial cancer known as p53abn.

Olaparib

What is already known about the treatment

Olaparib – Olaparib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating certain types of endometrial cancer, specifically in patients with a p53abn histological diagnosis. The main therapeutic indication for olaparib in this context is to improve recurrence-free survival after adjuvant chemoradiotherapy. At the molecular level, olaparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which helps repair damaged DNA in cells. By blocking this enzyme, olaparib prevents cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor in pharmacology.

Investigated diseases

Endometrial Cancer – Endometrial cancer is a type of cancer that begins in the lining of the uterus, known as the endometrium. It often presents with abnormal vaginal bleeding, especially after menopause. The disease progresses as cancer cells grow and may invade nearby tissues or spread to other parts of the body. In its early stages, it is usually confined to the uterus, but as it advances, it can affect the pelvic region and beyond. The progression can vary, with some cases remaining localized while others may metastasize. Regular monitoring and follow-up are crucial to understanding its progression.