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Study on Bevacizumab and Drug Combination for Patients with Resectable Colorectal Peritoneal Metastases

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What is this trial about?

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

This clinical trial is focused on studying treatments for peritoneal metastases that originate from colorectal cancer. Peritoneal metastases occur when cancer cells spread to the lining of the abdomen. The study involves a combination of surgery and various medications to see if this approach can improve patient outcomes. The medications being tested include Avastin (bevacizumab), Leucovorin-Teva (folinic acid), Oxaliplatin Eugia (oxaliplatin), Xeloda (capecitabine), 5-Fluorouracil Sandoz (fluorouracil), and Irinotecan Mylan Generics (irinotecan hydrochloride trihydrate). These medications are used in combination to target cancer cells and are administered either intravenously or orally.

The purpose of this study is to compare the effectiveness of chemotherapy and immunotherapy given before and after surgery with the standard approach of surgery alone. The study aims to determine if the additional treatments can improve overall survival rates for patients. Participants will receive treatment over a period of up to 12 months, with regular monitoring to assess the safety and effectiveness of the therapies. The study is designed to explore whether the combination of these treatments can provide better outcomes than surgery alone.

Throughout the study, participants will undergo various procedures, including HIPEC (Hyperthermic Intraperitoneal Chemotherapy), which involves applying heated chemotherapy directly into the abdominal cavity during surgery. This approach aims to kill any remaining cancer cells after the tumor has been surgically removed. The trial is structured to ensure that all participants receive the best possible care while contributing to important research that could benefit future patients with similar conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and diagnostic tests such as laparoscopy or imaging scans to ensure the disease is resectable.
Eligibility criteria include a performance status of 0 or 1, confirmed diagnosis of colorectal cancer with peritoneal metastases, and no recent systemic therapy or other interfering conditions.
Step 2
Preoperative systemic therapy
The treatment begins with preoperative systemic therapy, which involves administering a combination of medications to manage the cancer before surgery.
Medications include bevacizumab (Avastin) administered intravenously, folinic acid (Leucovorin) intravenously, oxaliplatin intravenously, capecitabine (Xeloda) taken orally, fluorouracil intravenously, and irinotecan intravenously.
The specific dosage and frequency are determined by the medical team based on individual patient needs.
Step 3
Surgical intervention
Following the systemic therapy, a surgical procedure known as cytoreductive surgery is performed to remove visible tumors.
This surgery is combined with a treatment called HIPEC (Hyperthermic Intraperitoneal Chemotherapy), where heated chemotherapy is applied directly to the abdominal cavity to target remaining cancer cells.
Step 4
Postoperative systemic therapy
After surgery, additional systemic therapy may be administered to further reduce the risk of cancer recurrence.
The same medications used in the preoperative phase may be continued, with adjustments made as necessary based on the patient's response and recovery.
Step 5
Follow-up and monitoring
Regular follow-up appointments are scheduled to monitor recovery and assess the effectiveness of the treatment.
These appointments may include physical examinations, imaging tests, and laboratory tests to check for any signs of cancer recurrence.

Who can join the trial?

12 criteria

The patient must have **resectable peritoneal metastases** from colorectal cancer. This means the cancer has spread to the lining of the abdomen but can be surgically removed.
The patient must have a **World Health Organisation (WHO) performance status** of 0 or 1. This is a scale that measures how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
The patient must have proof of cancer through a **histological or cytological** test. This means the cancer cells have been examined under a microscope.
The cancer must be a type called **non-appendiceal colorectal adenocarcinoma**, with no more than 50% of the tumor cells being **signet ring cells**. These are specific types of cancer cells.
The disease must be confirmed as resectable through a **diagnostic laparoscopy/laparotomy** and imaging tests like **CT or MRI**. These are procedures and scans to check if the cancer can be removed.
There must be no signs of cancer spreading to other parts of the body within three months before joining the study.
The patient must not have received any **systemic therapy** for colorectal cancer in the six months before joining the study. Systemic therapy is treatment that affects the entire body, like chemotherapy.
The patient must not have any medical reasons that would prevent them from undergoing **CRS-HIPEC**. This is a specific type of surgery and chemotherapy treatment.
The patient must not have had **CRS-HIPEC** before.
The patient must not have any other cancers that would interfere with the study treatment or affect the outcome of the surgery for colorectal cancer.
Both male and female patients are eligible to participate.
The study is open to adults, typically those aged 18 and older.

Who cannot join the trial?

3 criteria

Patients with medical conditions other than resectable peritoneal metastases of a colorectal origin cannot participate. This means the cancer has spread to the lining of the abdomen and can be surgically removed, and it started in the colon or rectum.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

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Verified sites

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Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

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Investigated drugs

Perioperative Systemic Therapy
is a treatment given around the time of surgery to help shrink tumors and kill cancer cells. It is used in this trial to see if it can improve outcomes for patients with colorectal cancer that has spread to the lining of the abdomen. This therapy is given before and after surgery to help reduce the risk of cancer returning.
Cytoreductive Surgery with HIPEC
involves surgically removing as much of the cancer as possible, followed by a special type of chemotherapy called Hyperthermic Intraperitoneal Chemotherapy (HIPEC). During HIPEC, heated chemotherapy is delivered directly into the abdominal cavity to target any remaining cancer cells. This approach is used to treat colorectal cancer that has spread to the peritoneum, aiming to improve survival and reduce recurrence.

What is already known about the treatment

HIPEC (Hyperthermic Intraperitoneal Chemotherapy) – This treatment is administered directly into the abdominal cavity during surgery, using heated chemotherapy drugs to target cancer cells. It is currently being studied in clinical trials for its effectiveness in treating resectable peritoneal metastases of colorectal origin. The main therapeutic indication is to improve survival rates in patients with this type of cancer. The mechanism of action involves the direct application of heated chemotherapy, which enhances the absorption and effectiveness of the drugs at the molecular level, potentially killing more cancer cells. HIPEC is classified under localized chemotherapy treatments.

Investigated diseases

Resectable Peritoneal Metastases of a Colorectal Origin – This condition occurs when cancer cells from the colon or rectum spread to the peritoneum, which is the lining of the abdominal cavity. These metastases are considered resectable, meaning they can potentially be removed through surgery. The disease progresses as cancer cells continue to grow and spread within the peritoneal cavity, potentially affecting other organs. Symptoms may include abdominal pain, bloating, and changes in bowel habits. The progression of the disease can lead to increased discomfort and complications related to the abdominal organs.