RecruitingRare disease

Study on Mitotane Alone or with Cisplatin and Etoposide for Patients with High-Risk Adrenocortical Carcinoma After Surgery

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What is this trial about?

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

This study focuses on adrenocortical carcinoma, a rare cancer that develops in the outer layer of the adrenal glands, which are small organs located above the kidneys that produce important hormones. The study will test different treatment approaches after surgical removal of the tumor in patients who have a high risk of the cancer returning. The treatments being studied include mitotane, a medication specifically used for adrenocortical carcinoma, either used alone or in combination with two chemotherapy drugs called cisplatin and etoposide. Additional medications will be used to support treatment and manage side effects, including fludrocortisone to help maintain hormone balance, filgrastim to support white blood cell production, ondansetron and metoclopramide to prevent nausea and vomiting, and electrolyte solutions to maintain proper body fluid balance.

The purpose of this study is to compare how well mitotane alone works compared to mitotane combined with cisplatin and etoposide in preventing the cancer from returning after surgery. Patients in the combination treatment group will receive four cycles of chemotherapy, with each cycle lasting 21 days, alongside their mitotane therapy. Throughout the study, participants will have regular check-ups that include physical examinations, blood tests to monitor general health and hormone levels, and imaging scans such as CT scans with contrast medium, MRI, or PET-CT scans to check for any signs of cancer recurrence. These imaging tests use different technologies to create detailed pictures of the inside of the body to detect any abnormal changes.

During the study, researchers will also evaluate how blood levels of mitotane, the stage of disease, certain tumor characteristics, and the completeness of surgical removal affect treatment outcomes. The study will assess how the timing of starting treatment after surgery may influence results, and participants will be asked to complete questionnaires about their quality of life at several time points. Safety will be carefully monitored by tracking any serious side effects that occur during treatment and for one year after treatment ends.

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
Randomization
Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization. It ensures that each participant has an equal chance of receiving either the treatment with mitotane alone or the combination of mitotane with cisplatin and etoposide.
Step 2
Treatment initiation
If assigned to the mitotane alone group, you will begin taking mitotane orally. The dosage and frequency will be determined by your healthcare provider based on your specific needs.
If assigned to the combination group, you will receive mitotane orally, along with cisplatin and etoposide administered intravenously. This treatment will occur in cycles, each lasting 21 days.
Step 3
Treatment cycles
For those in the combination group, the treatment involves four cycles of cisplatin and etoposide. Each cycle lasts 21 days, during which you will receive the medications intravenously on specific days as instructed by your healthcare provider.
Step 4
Monitoring and assessments
Throughout the trial, regular monitoring will occur. This includes physical examinations, blood tests, and imaging tests such as CT or MRI scans every 12 weeks to check for any signs of cancer recurrence.
Your healthcare team will also measure serum mitotane levels to ensure the treatment is working effectively.
Step 5
Quality of life assessments
Your quality of life will be assessed at the start of the treatment, after 6 weeks, after 6 months, and at the end of your participation in the study. This will involve completing a questionnaire designed to evaluate your overall well-being.
Step 6
End of study participation
Your participation in the study will conclude either when the treatment is completed or if there is a recurrence of the cancer. At this point, a final assessment will be conducted to evaluate your health status.

Who can join the trial?

8 criteria

Confirmed diagnosis of adrenocortical carcinoma (ACC) through a test called histology, with a Weiss score of 3 or higher. For a specific type called oncocytic ACC, a different system called Lin-Weiss-Bisceglia will be used.
High risk of the cancer coming back, defined as Stage I-III ACC, within 90 days after surgery to remove the tumor. The surgery should aim to cure, with no remaining cancer cells (R0), some remaining cancer cells (R1), or unclear if any cancer cells remain (RX). The Ki67 level, which is a measure of how fast cancer cells are growing, should be more than 10%.
Imaging tests like CT, MRI, or FDG-PET CT done within 12 weeks before joining the study, showing no clear evidence of cancer spread. Small, unclear nodules are allowed.
Must be 18 years of age or older.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which is a scale to assess how well a person can perform daily activities.
Women who can have children and men must use effective birth control to prevent pregnancy during the study.
Must be able to follow the study procedures.
Must provide written consent to participate in the study.

Who cannot join the trial?

9 criteria

Patients who have not had surgery to remove the tumor cannot participate.
Patients who have a different type of cancer other than adrenocortical carcinoma cannot participate.
Patients who are unable to take the study medications due to allergies or other medical reasons cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have severe heart problems cannot participate.
Patients who have severe liver or kidney problems cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have an active infection that requires treatment cannot participate.
Patients who have a history of another serious illness that could interfere with the study cannot participate.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Hospices Civils De Lyon
Responsive
Lyon, France
Ludwig Maximilian University Of Munich
Responsive
Munich, Germany

Trial locations

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Investigated drugs

Mitotane
is a medication used in this trial to help prevent the return of adrenocortical carcinoma, a type of cancer that affects the adrenal glands. It works by slowing down or stopping the growth of cancer cells. In this study, it is given to patients after they have had surgery to remove the cancer, to reduce the risk of the cancer coming back.
Cisplatin
is a chemotherapy drug used in this trial to treat cancer by killing cancer cells or stopping them from growing. It is used in combination with other medications to enhance its effectiveness. In this study, it is given to patients along with mitotane and etoposide to help prevent the recurrence of adrenocortical carcinoma after surgery.
Etoposide
is another chemotherapy medication used in this trial. It works by interfering with the DNA of cancer cells, which prevents them from dividing and growing. In this study, etoposide is used together with mitotane and cisplatin to help reduce the risk of cancer returning after surgery in patients with adrenocortical carcinoma.

What is already known about the treatment

Mitotane
Mitotane is taken orally in the form of tablets and is used to treat adrenocortical carcinoma, a type of cancer affecting the adrenal glands. It is currently recognized in medical literature as a treatment option for this condition, especially after surgical removal of the tumor. Mitotane works by altering the production of hormones in the adrenal glands and directly affecting cancer cells, helping to slow down or stop their growth. It is classified as an antineoplastic agent, which means it is used to prevent the growth and spread of tumors.
Cisplatin
Cisplatin is administered intravenously, meaning it is given through a vein, and is used in combination with other medications to treat various types of cancer, including adrenocortical carcinoma. It is well-established in medical literature as a chemotherapy drug. Cisplatin works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is classified as a platinum-based chemotherapy agent.
Etoposide
Etoposide is given either orally in capsule form or intravenously, and it is used alongside other medications to treat cancers such as adrenocortical carcinoma. It is a well-known treatment in medical literature. Etoposide works by inhibiting an enzyme that cancer cells need to divide and grow, thereby slowing or stopping their proliferation. It is classified as a topoisomerase inhibitor, a type of chemotherapy drug.

Investigated diseases

Adrenocortical carcinoma – Adrenocortical carcinoma is a rare cancer that originates in the outer layer of the adrenal glands, known as the adrenal cortex. This disease is characterized by the abnormal growth of cells in the adrenal cortex, which can lead to the production of excess hormones such as cortisol, aldosterone, and androgens. As the carcinoma progresses, it may cause symptoms related to hormone overproduction, such as weight gain, high blood pressure, and changes in physical appearance. The tumor can grow locally and may invade nearby tissues or spread to distant organs, a process known as metastasis. The progression of adrenocortical carcinoma can vary, with some tumors growing slowly while others may advance more rapidly. The disease is often detected through imaging studies when symptoms become apparent.