AuthorisedTherapeutic exploratory (Phase II)Interventional

PROSPECTIVE, PHASE II STUDY TO EVALUATE THE EFFICACY OF ADDITION OF PROGESTERONE TO STANDARD CHEMOTHERAPY ACCORDING TO EDP SCHEME PLUS MITOTANE IN PATIENTS WITH ADVANCED ADRENAL CORTICAL CARCINOMA - PESETA TRIAL

This study, called PESETA, is for people with advanced adrenal cortical carcinoma, a rare type of cancer that affects the adrenal glands. It's a Phase II study, which means researchers are checking if a new treatment approach is effective and safe. They want to see if adding a hormone called progesterone (MEGACE) to standard chemotherapy (a combination of DOXORUBICIN, CISPLATIN, and ETOPOSIDE) plus another drug called MITOTANE works better than the standard chemotherapy alone. They'll compare how many patients see their tumours shrink or disappear with each treatment. The aim is to find more effective ways to treat this challenging cancer.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Enrolment target

Start

31 Jan 2025

Adrenocortical carcinoma

What is this study about?

Adrenal cortical carcinoma is a rare cancer that starts in the adrenal glands, which are small glands located on top of your kidneys. These glands make important hormones. When this cancer is advanced, it means it has spread to other parts of the body, making it harder to treat.

This study, called PESETA, is trying to find better ways to treat patients with advanced adrenal cortical carcinoma. Currently, there's a standard way of treating this cancer with a combination of chemotherapy drugs. Researchers are wondering if adding two other medications – a hormone called progesterone (MEGACE) and another drug called mitotane – to the standard chemotherapy could make the treatment more effective.

The study will compare two groups of patients. One group will receive the standard chemotherapy plus mitotane, and the other group will receive the standard chemotherapy plus mitotane and progesterone. By comparing these two groups, doctors hope to learn if adding progesterone helps shrink the tumours more effectively. This type of study (Phase II) helps determine if a new treatment approach is promising enough to be studied in larger groups of patients later on.

Key takeaways

This study aims to find more effective treatments for advanced adrenal cortical carcinoma.
It compares standard chemotherapy plus mitotane with the same treatment plus progesterone.
It's a Phase II study, looking for signs of effectiveness and safety.
All adults (18+) with advanced adrenal cortical carcinoma are potentially eligible.
Participation involves regular treatments, tests, and closely monitored care.
You can withdraw from the study at any time without affecting your ongoing care.

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women can take part.

You would need to have been diagnosed with advanced adrenal cortical carcinoma, meaning the cancer has spread beyond the adrenal gland.

The research team will also check other things like your general health and specific details about your cancer to make sure the study treatment is suitable and safe for you. They will explain all the specific requirements in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with advanced adrenal cortical carcinoma?
Are you generally well enough to undergo cancer treatment?
Are you able to attend regular hospital appointments and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to one of two treatment groups, like flipping a coin. You wouldn't know which group you are in, and neither would your doctors or the study staff. This helps to ensure the results are accurate.

The treatment would involve receiving chemotherapy drugs, progesterone tablets, and mitotane. There would be regular hospital visits for your treatments, which would be given through a drip into your vein for the chemotherapy, and tablets for the other drugs. You would also have regular check-ups, blood tests, and scans (like CT or MRI scans) to see how you are responding to the treatment and to monitor your health.

The exact number and timing of visits, assessments, and the overall duration of your participation would depend on your individual treatment plan and how you respond to the medication. The study team would provide a detailed schedule covering the total duration of the study, including follow-up appointments after your main treatment period.

Potential risks and benefits

Taking part in a clinical trial might, but doesn't guarantee, lead to benefits if the new treatment proves to be more effective than existing ones. You would also be closely monitored by a medical team, which can be reassuring. However, all treatments, including those in clinical trials, come with potential risks and side effects. The chemotherapy drugs, progesterone, and mitotane can all cause side effects, which the study team will discuss with you in detail. These can range from mild to more serious, and the study team will work to manage them. Importantly, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is 'adrenal cortical carcinoma'?

It's a rare type of cancer that starts in the adrenal glands, which are small glands on top of your kidneys that make hormones.

What does a 'Phase II study' mean?

It means this is an early-stage study checking if a new treatment or approach is showing a good effect on the cancer and is safe enough to be studied further in more people.

What are the treatments being compared?

One group gets standard chemotherapy plus a drug called mitotane. The other group gets the same, but with the addition of a hormone called progesterone (MEGACE).

Will I know which treatment I'm receiving?

No, in this type of study, neither you nor your doctors will know which treatment you are getting. This helps ensure the results are fair and accurate.

What are 'RECIST criteria'?

These are standard rules doctors use to measure if a tumour has shrunk, grown, or stayed the same based on scans, helping them objectively assess how well a treatment is working.