Study on Pressurized Intraperitoneal Aerosol Chemotherapy with Fluorouracil for Patients with Gastric Cancer with Peritoneal Metastases

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What is this study about?

This clinical trial is focused on studying a type of stomach cancer known as gastric adenocarcinoma that has spread to the lining of the abdomen, referred to as peritoneal metastases. The study is investigating a treatment method called Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC), which is used in combination with other chemotherapy drugs. The chemotherapy drugs being studied include Fluorouracil, Docetaxel, Oxaliplatin, Calcium Levofolinate, Cisplatin, and Doxorubicin Hydrochloride. Additionally, a medication called Nivolumab, also known by its code name BMS936558, is part of the treatment regimen.

The purpose of this study is to determine if combining PIPAC with chemotherapy is more effective than using chemotherapy alone. The study will assess whether this combination increases the number of patients who can undergo surgery aimed at completely removing the cancer. It will also evaluate if the combination treatment helps patients live longer without the cancer getting worse. Participants in the study will receive treatment over a period of up to six months, with some receiving PIPAC in addition to chemotherapy, while others will receive chemotherapy alone. The study will monitor the effects of these treatments on the patients’ health and quality of life.

Throughout the study, the safety and side effects of the treatments will be closely observed. The study aims to provide valuable information on the potential benefits of using PIPAC in combination with chemotherapy for treating gastric adenocarcinoma with peritoneal metastases. The findings could help improve treatment options for patients with this type of cancer in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis, and health status.

Informed consent is required to participate in the trial.

2 randomization

Participants are randomly assigned to one of two treatment groups: Arm A or Arm B.

3 treatment in arm a

Participants receive chemotherapy alone.

Medications include fluorouracil, docetaxel, nivolumab, oxaliplatin, and calcium levofolinate, administered intravenously.

Treatment consists of 6 to 12 cycles, with each cycle followed by evaluation.

4 treatment in arm b

Participants receive a combination of chemotherapy and pressurized intraperitoneal aerosol chemotherapy (PIPAC).

Chemotherapy medications include fluorouracil, docetaxel, nivolumab, oxaliplatin, and calcium levofolinate, administered intravenously.

PIPAC involves the use of cisplatin and doxorubicin hydrochloride, administered intraperitoneally.

Treatment consists of 6 cycles of chemotherapy and 3 PIPAC procedures.

5 evaluation and monitoring

Progress is monitored through regular assessments, including imaging and biopsies.

Quality of life is assessed using a questionnaire.

Adverse events are recorded and evaluated.

6 surgery consideration

The possibility of surgery with radical intent is evaluated based on treatment response.

Surgery may involve cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC).

7 follow-up

Participants are followed up to assess overall survival and progression-free survival.

Long-term outcomes are compared between the two treatment groups.

Who Can Join the Study?

Age between 18-75 years
Have a first diagnosis of a type of stomach cancer called primary gastric adenocarcinoma that has not been treated before
Have a laparoscopic finding (a procedure using a small camera to look inside the abdomen) showing positive peritoneal cytology (cancer cells in the lining of the abdomen) and/or disease in the abdomen with a PCI (Peritoneal Cancer Index) of 6 or less, confirmed by a tissue test
Sign an informed consent form, which means you agree to participate in the study after understanding the details
Have an ECOG PS scale of 0-1, which is a measure of your ability to perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work
If you are of childbearing potential, you will be included in the study and monitored with blood pregnancy tests before each chemotherapy cycle and each PIPAC (a type of treatment) and at the end of treatment. Oral contraceptives will not be used due to the high risk of blood clots related to the disease, but other contraceptives will be used according to guidelines.

Who Cannot Join the Study?

Patients who do not have gastric adenocarcinoma with peritoneal metastases. This means the study is only for those with a specific type of stomach cancer that has spread to the lining of the abdomen.
Patients who are not within the specified age range. The study is open to certain age groups, so those outside these groups cannot participate.
Patients who are part of a vulnerable population. This means people who might need special protection or care, like those with certain disabilities or conditions, are not included.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliera Di Perugia	Perugia	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Arbfheu Ogkrulsotmq Uyoqoqbzvwyfi Sofzls	Siena	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	14.12.2022

Trial locations

Investigated drugs:

PIPAC is a therapy used in this trial. It stands for Pressurized Intraperitoneal Aerosol Chemotherapy. This method involves delivering chemotherapy directly into the abdominal cavity in the form of a pressurized aerosol. The goal is to target cancer cells more effectively in patients with peritoneal gastric cancer, potentially improving outcomes when combined with other treatments.

CRS and HIPEC are surgical procedures that may be part of the treatment plan in this trial. CRS stands for Cytoreductive Surgery, which involves removing visible tumors from the abdominal cavity. HIPEC stands for Hyperthermic Intraperitoneal Chemotherapy, a procedure where heated chemotherapy is applied directly inside the abdomen after surgery to kill any remaining cancer cells. These procedures aim to achieve a more complete removal of cancer and improve patient survival.

Gastric adenocarcinoma with peritoneal metastases – This is a type of cancer that begins in the glandular cells of the stomach lining and spreads to the peritoneum, the tissue lining the abdominal wall and covering abdominal organs. The disease often progresses as cancer cells detach from the primary tumor in the stomach and implant themselves on the peritoneal surfaces. This spread can lead to the formation of new tumor nodules in the abdominal cavity, causing symptoms such as abdominal pain, bloating, and changes in bowel habits. As the disease advances, it can interfere with the function of abdominal organs and lead to fluid accumulation in the abdomen, known as ascites. The progression of this cancer is typically aggressive, with the potential for further spread to other organs.

Trial ID:

2024-515981-14-00

Protocol code:

PIPAC_VEROne

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pressurized Intraperitoneal Aerosol Chemotherapy with Fluorouracil for Patients with Gastric Cancer with Peritoneal Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?