Study on Capecitabine and Cyclophosphamide for Patients with Large Pseudomyxoma Peritonei Preparing for Surgery and Chemotherapy

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What is this study about?

This clinical trial is focused on studying a condition called Pseudomyxoma Peritonei (PMP), which is a rare type of cancer that causes a buildup of mucus in the abdomen. The study involves patients with a high tumor burden, meaning they have a large amount of tumor present. The treatment being tested includes two medications: Capecitabine and Cyclophosphamide. These medications are taken orally in the form of tablets. The purpose of the study is to evaluate how effective this treatment is in helping patients achieve complete removal of the tumor through surgery.

Participants in the study will receive the medications Capecitabine and Cyclophosphamide over a period of six months. The treatment is given before a surgical procedure called cytoreductive surgery, which aims to remove as much of the tumor as possible. This is followed by a special type of chemotherapy called hyperthermic intraperitoneal chemotherapy (HIPEC), which is administered directly into the abdomen to target any remaining cancer cells. The study will monitor the patients’ response to the treatment and the surgery, as well as their overall health and quality of life during and after the treatment.

The trial aims to determine the proportion of patients who achieve complete tumor removal after receiving the treatment. It will also assess the safety and tolerability of the medications, as well as the impact on patients’ quality of life. The study will involve regular check-ups and imaging tests, such as CT scans, to evaluate the size of the tumor and the effectiveness of the treatment. The trial is expected to continue until 2029, with recruitment starting in 2024.

1 initiation of treatment

Upon joining the study, the patient begins treatment with two medications: capecitabine and cyclophosphamide.

Both medications are administered orally in the form of tablets. Capecitabine is provided as a film-coated tablet, while cyclophosphamide is provided as a coated tablet.

2 medication regimen

The patient takes capecitabine and cyclophosphamide according to the prescribed dosage and schedule. The specific dosage and frequency are determined by the healthcare provider based on individual patient needs and study protocols.

3 monitoring and assessments

Throughout the treatment period, the patient undergoes regular monitoring to assess the response to the medication. This includes CT scans to evaluate tumor size and response.

The patient’s health and any side effects are closely monitored to ensure safety and tolerability of the treatment.

4 surgical evaluation

After 16 weeks of treatment, the patient is evaluated for potential surgery. This involves assessing the possibility of complete tumor removal through a procedure known as cytoreductive surgery (CRS).

The decision for surgery is based on the reduction in tumor size and other clinical factors.

5 post-treatment follow-up

Following the treatment and any surgical procedures, the patient continues to be monitored for progression-free survival and overall survival.

Quality of life assessments are conducted before and after treatment, and 30 days post-surgery, to evaluate the impact of the treatment on the patient’s well-being.

Who Can Join the Study?

Have a clinical or histological diagnosis of pseudomyxoma peritonei (PMP), which is a specific type of cancer affecting the lining of the abdomen.
Sign an informed consent document (ICD), which means you agree to participate in the study after understanding all the details.
If you are a male or female with the potential to have children, you must use an approved method of birth control.
Have a Peritoneal Cancer Index (PCI) greater than 28, which is a score that measures the extent of cancer in the abdomen, assessed by a CT scan.
Be between the ages of 18 and 75 years old.
Have a Performance Status (ECOG) of less than 2, which is a scale that measures your ability to perform daily activities.
Have adequate organ function, meaning your organs are working well enough to participate in the study.
Have adequate bone marrow reserve, which includes having a white blood cell count greater than 3.0×10^9/L, an absolute neutrophil count greater than 1.5×10^9/L, a platelet count greater than 100×10^9/L, and hemoglobin greater than 10 g/dL.
Have adequate liver function, with bilirubin less than 1.5 times the upper limit of normal (ULN), and other liver enzymes less than 2.5 times the ULN.
Have adequate kidney function, with creatinine clearance greater than 50 mL/min or serum creatinine less than 1.5 times the ULN.
Be able to comply with the study requirements and live close enough to the study site for proper follow-up.

Who Cannot Join the Study?

Patients who are not diagnosed with Pseudomyxoma peritonei, a condition where a jelly-like substance builds up in the belly.
Patients who do not have a high amount of tumor in their body.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	30.06.2024

Trial locations

Investigated drugs:

Capecitabine is a medication used in this trial as part of a neoadjuvant treatment approach. It is an oral chemotherapy drug that helps to slow or stop the growth of cancer cells. In this study, it is used to treat patients with a condition called Pseudomyxoma peritonei (PMP) before they undergo surgery.

Cyclophosphamide is another medication used in this trial alongside capecitabine. It is also a chemotherapy drug that works by interfering with the growth and spread of cancer cells. In this study, it is used to help reduce the size of the tumor in patients with PMP, making it easier to remove during surgery.

Investigated diseases:

Pseudomyxoma peritonei

Pseudomyxoma Peritonei – This is a rare condition characterized by the accumulation of mucinous tumors in the abdominal cavity, often originating from the appendix. The disease progresses as the mucinous material spreads throughout the peritoneal cavity, leading to increased abdominal girth and discomfort. Over time, the buildup of mucin can cause pressure on internal organs, potentially affecting their function. The condition is typically slow-growing, but the tumor burden can become significant, necessitating medical intervention. It is often discovered incidentally during surgeries for other conditions or through imaging studies. The progression of the disease can vary, with some patients experiencing more rapid accumulation of mucin than others.

Trial ID:

2024-514329-42-00

Protocol code:

REVERSE

Trial Phase:

Therapeutic exploratory (Phase II)

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