Study on Regorafenib with Cyclophosphamide, Capecitabine, and Aspirin for Patients with Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and has spread to other parts of the body. The study will explore the use of several medications, including Regorafenib (also known by its code name BAY 73-4506), Capecitabine (marketed as Xeloda), Cyclophosphamide (marketed as Endoxan), and low-dose Aspirin (marketed as Kardegic). Additionally, the study will involve chemotherapy drugs such as Oxaliplatin, Irinotecan, Bevacizumab, and Fluorouracil.

The purpose of the study is to evaluate the effectiveness of using Regorafenib in combination with other treatments as an initial therapy before starting chemotherapy for patients with metastatic colorectal cancer. The study will be conducted in two phases. In the first phase, the focus will be on the best response to the treatment, while the second phase will look at overall survival, which means how long patients live after starting the treatment.

Participants in the study will receive the combination of medications for a period of two months. After this initial treatment, they will proceed to receive chemotherapy. The study aims to determine if this approach can improve the response to treatment and increase the survival time for patients with metastatic colorectal cancer. The trial will also monitor the safety and any side effects of the treatments used.

1 induction therapy

The initial phase involves taking regorafenib in combination with metronomic cyclophosphamide, capecitabine, and low-dose aspirin for a duration of 2 months.

Regorafenib is administered orally. Cyclophosphamide and capecitabine are also taken orally, while aspirin is taken in a low-dose oral form.

2 chemotherapy initiation

Following the induction therapy, chemotherapy is initiated as the second line of treatment for metastatic colorectal cancer.

The specific chemotherapy regimen will be determined based on individual patient needs and response to the induction therapy.

3 treatment evaluation

During the treatment period, the best objective response is evaluated using specific criteria to assess the effectiveness of the therapy.

This evaluation helps in determining the overall survival and progression-free survival of the patient.

4 ongoing monitoring

Throughout the trial, regular monitoring is conducted to assess health-related quality of life and any adverse events.

Patients may be required to complete questionnaires and undergo various assessments to track their response to treatment and any side effects experienced.

Who Can Join the Study?

Patients must have metastatic colorectal cancer that has been confirmed by a lab test and is getting worse after the first round of chemotherapy, with or without additional targeted therapy.
There should be no issues with using iodine contrast media during a CT scan. This is a special dye used to improve the clarity of the images.
Women who can have children must have a negative pregnancy test within 14 days before starting the study drug and continue to use birth control during the study and for 210 days after the last dose of the study drug. Men must also use birth control during the study.
Participants must sign and date a form to show they understand and agree to the study.
Participants must be able to follow the study rules, as judged by the study doctor.
Participants must be registered in a national health care system.
Participants must have been treated for their metastatic disease with specific chemotherapy regimens as the first treatment. These include FOLFOX, FOLFIRI, FOLFIRINOX, FOLFOXIRI, and combinations with anti-VEGFA (like bevacizumab) or anti-EGFR.
Participants should have shown resistance to the first line of chemotherapy, meaning the disease got worse during or shortly after the first treatment, or came back within 6 months after stopping treatment or surgery.
Participants should have a life expectancy of at least 3 months.
Participants must be 18 years or older.
Participants should have a performance status of 0 or 1 according to the ECOG-WHO scale, which measures how well they can perform daily activities.
Participants must have a measurable disease as defined by specific imaging criteria (RECIST v1.1).
Participants must have a specific molecular status: microsatellite-stable (MSS), no BRAF V600E mutation, and a known RAS status.
Participants must have adequate bone marrow, liver, and kidney functions. This includes specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, kidney filtration rate, and protein in urine.

Who Cannot Join the Study?

Patients with other types of cancer besides metastatic colorectal cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centr Georges Francois Leclerc	Dijon	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Hôpital Européen Georges-Pompidou	Paris	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Prive Jean Mermoz	Lyon	France
Centre Hospitalier Regional Universitaire	Besançon	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Hopital Nord Franche-Comte	Belfort	France
Cqkbxl Hjsqlizkffi Uaulgypodcwek Rqepw	Reims	France
Imbzvezk Mhsvhgregl Myzvlsdela	Paris	France
Uapztzmlkz Haxqsesag Psiah Spzyjuxxohb Czpmfyl Fcec	Paris	France
Hgyhbzl Hrxru Mittxm &ybohsi 1 rhg Gmsncyu Ebmxir	Creteil	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	27.09.2022

Trial locations

Investigated drugs:

Regorafenib is a medication used in this trial as part of an induction therapy. It is designed to help control the growth of cancer cells in patients with metastatic colorectal cancer. It works by blocking certain proteins that promote cancer cell growth.

Cyclophosphamide is a chemotherapy drug used in this trial in a metronomic (low-dose, continuous) manner. It helps to slow or stop the growth of cancer cells by interfering with their DNA.

Capecitabine is another chemotherapy medication included in the trial. It is taken orally and works by interfering with the DNA production of cancer cells, which prevents them from growing and dividing.

Aspirin is used in a low-dose form in this trial. It is commonly known for its pain-relieving and anti-inflammatory effects, but in this context, it is used to potentially enhance the effects of the other cancer treatments.

Investigated diseases:

Colorectal cancer metastatic

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs, such as the liver or lungs. The disease may cause symptoms like changes in bowel habits, abdominal pain, and weight loss. As it advances, it can lead to more severe symptoms depending on the organs affected. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower course. The focus of treatment often involves managing symptoms and slowing the spread of cancer.

Trial ID:

2024-516709-22-00

Trial Phase:

Therapeutic use (Phase IV)

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Study on Regorafenib with Cyclophosphamide, Capecitabine, and Aspirin for Patients with Metastatic Colorectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?