AuthorisedTherapeutic exploratory (Phase II)Interventional

Hyperthermic Intraperitoneal Chemotherapy and Regional Adrenalectomy in the management of Stage II & III Adrenocortical Carcinoma

Adrenal gland cancer is a rare condition. In stages 2 and 3, the tumour has grown larger and has a higher risk of coming back after standard surgery. This trial tests a treatment that combines surgery with a heated chemotherapy wash inside the tummy, known as HIPEC. During the operation, surgeons remove the affected adrenal gland and nearby tissue. They then gently wash the area with warm chemotherapy medicines, called cisplatin and doxorubicin, to kill any tiny cancer cells left behind. A medicine called thiosulfate is also used to protect the kidneys from side effects. Researchers want to see how many people stay free of cancer in the abdomen for up to three years after surgery. They will also carefully track recovery, side effects, and overall health to find out if this treatment is safe and effective.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Enrolment target

Start

02 Sep 2026

Adrenocortical Carcinoma

What is this study about?

The adrenal glands sit just above your kidneys and produce important hormones. Adrenocortical carcinoma is a rare cancer that starts in these glands. When the cancer is diagnosed at stage 2 or stage 3, it means the tumour has grown larger or spread into nearby areas, but has not yet travelled to distant parts of the body. Standard care usually involves surgery to remove the tumour, but there is still a risk that invisible cancer cells remain behind and cause the cancer to return.

To tackle this problem, researchers are testing a technique called hyperthermic intraperitoneal chemotherapy, or HIPEC. In this approach, after the surgeon removes the tumour, a warm solution containing chemotherapy medicines is circulated inside the tummy for a set period. Warming the chemotherapy helps the medicine penetrate tissues more deeply and kill remaining cancer cells more effectively than room-temperature drugs.

This study is a phase 2 trial. Its primary purpose is to see whether this heated chemotherapy wash successfully stops the cancer from returning in the abdomen over a 36-month period. Doctors also want to understand the safety of the procedure, looking closely at recovery times, surgical complications, and patient well-being over three years.

Key takeaways

The trial tests combining tumour surgery with a heated chemotherapy wash inside the tummy.
It is designed for adults with stage 2 or stage 3 adrenal gland cancer.
The main goal is to find out if this treatment stops cancer returning over three years.
Medicines used include cisplatin, doxorubicin, and a kidney-protective drug called thiosulfate.
Follow-up care and regular health scans continue for 36 months after surgery.

Who may be eligible?

This trial is for adults aged 18 and older who have been diagnosed with stage 2 or stage 3 adrenocortical carcinoma. It is open to people of all genders.

Because this approach involves major surgery combined with chemotherapy, participants must be well enough to safely undergo an operation. Your healthcare team will look closely at your general fitness, heart health, and how well your kidneys and liver are functioning.

People whose cancer has already spread to distant organs, such as the lungs or bones (stage 4), will generally not be able to join. Your doctor can confirm your exact cancer stage and explain whether this study matches your health needs.

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.

I am aged 18 or older.
I have been diagnosed with adrenocortical carcinoma (adrenal gland cancer).
My cancer is stage 2 or stage 3.
My cancer has not spread to distant parts of my body, such as my lungs.
A doctor has confirmed that I am fit enough for major surgery.

Answer every question to see your result.

What does participation involve?

If you take part, your care will begin with thorough health checks, including blood tests, heart checks, and scans to confirm the tumour's exact size and position. You will then have an operation under general anaesthetic to remove the adrenal tumour and surrounding tissue. While you are still asleep, the team will circulate the heated chemotherapy medicines (cisplatin and doxorubicin) inside your abdomen, alongside a protective medicine called thiosulfate to look after your kidneys. After surgery, you will stay in hospital while your surgical team monitors your recovery and manages any discomfort. Once you return home, you will attend regular clinic appointments over a total period of 36 months (three years). These visits will involve physical examinations, routine blood tests, and imaging scans to check your healing and make sure the cancer has not returned.

Potential risks and benefits

Taking part may help lower the chances of the cancer returning in your abdomen, but this cannot be guaranteed. The information gathered may also help doctors improve treatments for other people with adrenal cancer in the future. However, combining major surgery with heated chemotherapy carries risks. These include typical surgical complications such as bleeding, wound infection, and blood clots, as well as chemotherapy-related side effects such as nausea, tiredness, bowel irritation, or strain on your kidneys. Your medical team will monitor you very closely to prevent and treat any problems. Taking part is completely voluntary, and you can choose to withdraw from the trial at any time without your regular NHS care being affected.

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 does HIPEC stand for?

HIPEC stands for Hyperthermic Intraperitoneal Chemotherapy. It simply means delivering heated chemotherapy medicine directly into the tummy during surgery.

Why is the chemotherapy heated?

Warming the chemotherapy medicine makes it easier for the drugs to enter cancer cells and helps them work more effectively against any tiny cells left behind.

Will I be awake during the chemotherapy wash?

No. The entire procedure, including the surgery and the heated wash, takes place while you are fully asleep under general anaesthetic.

What is thiosulfate used for?

Thiosulfate is a protective medicine given through a drip to help protect your kidneys from being damaged by the chemotherapy drugs.

Can I leave the trial if I change my mind?

Yes. Joining a clinical trial is entirely your choice. You can decide to leave at any stage, and your usual medical team will continue to support you with standard treatment.