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Study on Encorafenib and Cetuximab for Patients with BRAF V600E-Mutated Localized Colon or Upper Rectum Cancer

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What is this study about?

This clinical trial is focused on studying a specific type of cancer known as . This type of cancer involves a mutation in the BRAF gene, which can affect how cancer cells grow. The study is testing a combination of two treatments: and . is a medication that targets the BRAF mutation, while is a protein-based treatment that helps block cancer cell growth. These treatments are being used together in a setting called “neoadjuvant,” which means they are given before the main treatment, such as surgery, to help shrink the tumor.

The purpose of this study is to see how well the combination of and works in reducing the size of the tumor in patients with this specific type of cancer. The study will involve patients receiving these treatments over a period of time, and their progress will be monitored through various medical assessments. Some patients may receive a as part of the study to help compare the effects of the actual treatment. The study aims to gather information on the safety of the treatment, how long patients live after treatment, and how the cancer responds to the treatment.

Participants in the study will undergo regular check-ups and imaging tests to track the changes in their cancer. The study will also look at the overall quality of life of the participants during and after the treatment. The results of this study could provide valuable insights into the effectiveness of using and together for treating .

1 joining the study

Upon joining the study, informed consent must be signed. This confirms understanding and agreement to participate.

Eligibility is confirmed based on specific health criteria, including age, medical history, and current health status.

2 initial assessment

An initial assessment is conducted to evaluate the current state of the cancer. This includes imaging tests and laboratory evaluations to confirm the presence of the BRAF V600E mutation.

3 treatment phase

The treatment involves a combination of two medications: cetuximab and encorafenib.

Cetuximab is administered through an intravenous infusion. The frequency and dosage are determined by the healthcare provider based on individual needs.

Encorafenib is taken orally in the form of hard capsules. The dosage is 75 mg, and the frequency is specified by the healthcare provider.

4 monitoring and evaluation

Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and laboratory evaluations.

The primary goal is to evaluate the tumour regression rate using specific criteria.

5 surgery

If the tumour shows significant regression, surgery may be performed to remove the remaining cancerous tissue.

Post-surgery, a centralised review is conducted to assess the outcome.

6 follow-up

After surgery, follow-up appointments are scheduled to monitor recovery and overall health.

The study also evaluates overall survival, progression-free survival, and quality of life.

Who Can Join the Study?

  • The patient must give their permission to participate by signing a consent form.
  • The patient must have certain blood test results: serum total bilirubin should be 25 or less, and ALT and/or AST should be 2.5 times or less than the upper normal limit.
  • The patient’s heart function should be satisfactory, with a QT interval (a measure of heart rhythm) of 480 milliseconds or less.
  • The patient must be able to take medicine by mouth.
  • Female patients must be postmenopausal for at least one year, surgically unable to have children for at least six weeks, or use effective birth control. Male patients must also use effective birth control for two months after treatment.
  • Female patients who can have children must have a negative pregnancy test before joining the study.
  • The patient must be covered by the French Social Security system.
  • The patient must be between 18 and 75 years old at the time of giving consent.
  • The patient must have a specific type of colon or upper rectum cancer that is operable and confirmed by a biopsy to have a BRAF V600E mutation.
  • The cancer must be at a certain stage, with a tumor that extends 5 millimeters or more outside the wall of the colon or rectum, as seen on a CT scan.
  • The patient must be able to provide a sufficient sample of their tumor for analysis.
  • The patient must have a WHO performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
  • The patient must have satisfactory blood cell counts: neutrophils (a type of white blood cell) of 1,500 or more, platelets of 100,000 or more, and hemoglobin of 9 grams per deciliter or more.
  • The patient must have a creatinine clearance (a measure of kidney function) greater than 50 milliliters per minute.
  • The patient’s serum magnesium levels must be within normal limits.

Who Cannot Join the Study?

  • Patients who do not have a BRAF V600E mutation in their colon or upper rectum cancer. This is a specific change in the cancer cells that the study is focusing on.
  • Patients whose cancer is not localized, meaning the cancer has spread to other parts of the body.
  • Patients who have a RAS mutation. This is another type of change in the cancer cells that is not suitable for this study.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had certain treatments recently that might affect the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Aix Marseille University Marseille France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Bethune Beuvry Beuvry France
Clinique De La Sauvegarde Lyon France
Hopital Europeen Marseille Marseille France
Hopital Prive Jean Mermoz Lyon France
Centre Hospitalier Pays de Morlaix Morlaix France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Saint Joseph Marseille France
Hopital Prive Des Cotes D’armor Plerin France
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Centre Hospitalier Universitaire De Rennes Rennes France
Hopital Beaujon Clichy France
Institut Sainte Catherine Avignon France
Centre Hospitalier De Pau Pau France
Groupe Hospitalier Rance Emeraude Saint-Malo France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
03.05.2023

Trial locations

Investigated drugs:

Encorafenib is a medication used in this trial to target and inhibit a specific mutation known as BRAF V600E. This mutation is found in some types of cancer, including certain colon cancers. By blocking the activity of this mutation, encorafenib aims to slow down or stop the growth of cancer cells.

Cetuximab is another medication used in the trial, which works by targeting a protein on the surface of cancer cells called EGFR (epidermal growth factor receptor). By binding to this protein, cetuximab helps to prevent the cancer cells from growing and dividing. It is used in combination with encorafenib to enhance the treatment’s effectiveness against the cancer.

Investigated diseases:

BRAF V600E-Mutated Localized Colon or Upper Rectum Cancer – This is a type of cancer that occurs in the colon or the upper part of the rectum and is characterized by a specific genetic mutation known as BRAF V600E. This mutation leads to changes in the cells that cause them to grow uncontrollably, forming a tumor. The cancer is considered localized, meaning it has not spread to other parts of the body. Over time, the tumor may grow larger and potentially invade nearby tissues. The progression of this cancer can vary, but it typically involves the gradual worsening of symptoms related to bowel function. The presence of the BRAF V600E mutation can influence the behavior and progression of the cancer.

Trial ID:
2024-514107-34-00
Protocol code:
FFCD 2006 NEORAF
NCT ID:
NCT05706779
Trial Phase:
Therapeutic exploratory (Phase II)

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