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Cisplatin with drug combination in hyperthermic intraperitoneal chemotherapy for stage II‑III adrenocortical carcinoma patients

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What is this trial about?

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

The trial focuses on Adrenocortical Carcinoma, a rare cancer that starts in the outer layer of the adrenal gland. Participants will undergo regional adrenalectomy, a surgical removal of the affected adrenal gland, followed by a heated chemotherapy treatment delivered directly into the abdominal cavity, known as hyperthermic intraperitoneal chemotherapy. The chemotherapy mixture includes the drugs cisplatin, doxorubicin hydrochloride, and a protective combination of sodium nitrite and sodium thiosulfate given through an IV infusion.

The purpose of the study is to see whether this approach reduces the chance of the cancer coming back in the abdomen or nearby areas. After surgery, patients will be monitored with regular physical checks, blood tests, and imaging scans such as computed tomography performed with and without contrast every four months for up to three years. The follow‑up schedule also records any serious complications or deaths that occur shortly after the operation.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessments
After joining the study, you will have a series of baseline tests to document the current status of your disease. these include a clinical examination, blood tests that measure biochemical markers, and a thoraco‑abdominal CT scan performed with and without contrast.
The results of these assessments are used to compare later findings and to confirm that you meet the study criteria.
Step 2
Regional adrenalectomy surgery
You will undergo a surgical procedure called regional adrenalectomy, in which the affected adrenal gland and surrounding tissue are removed.
The operation is performed under general anesthesia and is the first step before the chemotherapy is given inside the abdomen.
Step 3
Hyperthermic intraperitoneal chemotherapy (HIPEC)
Immediately after the adrenalectomy, the surgeon will perform HIPEC, which stands for hyperthermic intraperitoneal chemotherapy. this involves circulating heated chemotherapy fluid throughout the abdominal cavity for a short period.
The chemotherapy fluid contains two drugs:
cisplatin given at a dose of 70 mg per square meter of body surface area, and doxorubicin given at a dose of 15 mg per square meter. both drugs are administered intraperitoneally, meaning they are placed directly into the abdomen.
At the same time, you will receive an intravenous infusion of thiosulfate at a dose of 21 g per square meter. this infusion is given through a vein to help reduce potential toxicity from the chemotherapy.
All three medications are given once, during the HIPEC procedure, which typically lasts about 60 to 90 minutes.
Step 4
Immediate postoperative monitoring
After the HIPEC session, you will be taken to a recovery area where nurses and doctors will monitor your vital signs, kidney function, and blood counts closely.
Additional blood tests may be performed to check how your body is responding to the chemotherapy and to detect any early side effects.
Step 5
Hospital discharge and recovery at home
Once the medical team determines that you are stable, you will be discharged home. you will receive written instructions on activity limits, wound care, and signs of infection or other complications to watch for.
You will be asked to keep a medication diary and to report any unexpected symptoms to your treating physician.
Step 6
Scheduled follow‑up visits
Starting four months after surgery, you will attend a follow‑up visit every four months for a total period of 36 months.
Each visit includes a clinical examination, repeat blood biochemical tests, and a thoraco‑abdominal CT scan with and without contrast to look for any local or peritoneal recurrence of the cancer.
The timing of these visits is designed to monitor your health closely and to assess the long‑term effect of the treatment.
Step 7
Final 36‑month assessment
At the end of the 36‑month follow‑up period, a comprehensive assessment will be performed to determine whether the disease has recurred and to evaluate overall survival.
The results are compared with the study’s primary and secondary goals, which focus on recurrence rates, major complications, and survival outcomes.

Who can join the trial?

8 criteria

Be a man or woman who is at least 18 years old.
Have a pre‑surgery diagnosis of adrenocortical carcinoma (ACC) that is classified as ENS@T stage II or III (a system doctors use to describe how far the cancer has spread).
Not have received any previous treatments for ACC except possibly the medicine mitotane (a drug used to treat this type of cancer).
Have a recommendation from a team of doctors from different specialties (multidisciplinary indication) that surgery should be done first (upfront surgery).
If you are a woman who could become pregnant, you must have a negative blood or urine pregnancy test within 24 hours before the study starts.
If you are a woman, you must not be breastfeeding.
Be willing and able to attend clinic visits and follow all study‑related procedures.
Be willing and able to sign an informed consent form, showing that you understand and agree to take part in the study.

Who cannot join the trial?

10 criteria

Any surgery that is only an exploratory test or is not performed according to the proper guidelines for a regional adrenalectomy (the operation to remove the adrenal gland).
If the laboratory examination of the removed tissue (histological diagnosis) shows that the tumor is not an adrenocortical carcinoma (ACC), the patient cannot join.
If the tissue test confirms a diagnosis other than ACC.
If the cancer is classified as stage I or stage IV according to the ENS@T system (stage I = early disease, stage IV = spread to distant organs).
If the patient’s overall health rating, measured by the ECOG performance status, is higher than 1, indicating significant limitation in daily activities.
If the patient has other serious health problems at the same time (intercurrent clinical conditions), such as infections that cannot be controlled or heart failure, which would make surgery unsafe.
If the patient has a large clot (thrombosis) in the inferior vena cava (the main vein returning blood to the heart) that would require a blood‑vessel replacement or a machine that takes over heart and lung function (extracorporeal circulation).
If the patient is pregnant.
If a woman who could become pregnant or a sexually active man does not agree to use a highly effective contraception method for at least six months after the treatment (HIPEC).
If the patient refuses to sign the informed consent form that explains the study.

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Verified sites

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Universita Degli Studi Di Brescia
Brescia, Italy

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Investigated drugs

Thiosulfate
is a medication given through an IV drip. It contains two substances, sodium nitrite and sodium thiosulfate, that help protect the body’s normal cells from the effects of the chemotherapy used in the study. In this trial it is used as background treatment to reduce side‑effects and improve safety.
Cisplatin
is a chemotherapy drug that is placed directly into the abdomen during the hyperthermic intraperitoneal chemotherapy (HIPEC) procedure. It works by damaging the DNA of cancer cells, which helps stop them from growing and spreading. In this study it is one of the active agents being tested to see if it lowers the chance of the cancer coming back in the abdomen.
Doxorubicin
is another chemotherapy medicine used during the HIPEC treatment. It is also delivered straight into the abdominal cavity. Doxorubicin attacks cancer cells by interfering with their ability to make new DNA, which can kill the cells or stop them from multiplying. The trial is evaluating whether adding this drug to the HIPEC procedure helps prevent local or peritoneal recurrence of adrenocortical carcinoma.

What is already known about the treatment

Thiosulfate
This medication is given by intravenous infusion and contains sodium nitrite and sodium thiosulfate. It is an approved antidote that is widely used to treat cyanide poisoning and is also studied for protecting kidneys during high‑dose chemotherapy. The main purpose is to turn harmful cyanide into a harmless substance that the body can remove. It belongs to the class of sulfur‑donor antidotes that help detoxify dangerous chemicals.
Cisplatin
Cisplatin is applied directly into the abdominal cavity (intraperitoneal use) as part of hyperthermic chemotherapy. It is a long‑standing cancer drug that is listed in medical guidelines for many solid tumors and is now being tested for adrenocortical carcinoma. The drug works by attaching to DNA inside cancer cells, which stops the cells from dividing and leads to their death. It is classified as a platinum‑based antineoplastic agent.
Doxorubicin
Doxorubicin hydrochloride is also delivered by intraperitoneal infusion during the heated chemotherapy procedure. It is a well‑known chemotherapy medicine used for a wide range of cancers and is being evaluated for use in adrenocortical carcinoma. It kills cancer cells by slipping between DNA strands and creating free radicals that damage the cell’s machinery. This drug belongs to the anthracycline class of antineoplastic antibiotics.

Investigated diseases

Adrenocortical carcinoma - A malignant tumor that originates in the outer layer of the adrenal glands, which produce hormones. It typically begins as a small mass and can enlarge to invade surrounding tissues in the abdomen. Over time the cancer may spread locally to nearby organs or seed the peritoneal cavity, leading to new tumor deposits. The disease can progress silently, with growth detectable only through imaging or changes in hormone levels. Recurrence often appears as new growths in the site of the original tumor or within the abdominal lining.