Comparing drug combinations with panitumumab for patients with RAS and B-RAF wild-type metastatic colorectal cancer

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What is this study about?

This clinical trial focuses on patients with metastatic colorectal cancer who have specific genetic characteristics – namely RAS and B-RAF wild-type mutations, which are determined through a blood test analyzing circulating cell-free DNA. The study compares two different combination treatments: FOLFIRINOX plus panitumumab versus mFOLFOX6 plus panitumumab.

The treatment combinations include several medications given through infusion or injection. The first combination consists of oxaliplatin, irinotecan, fluorouracil, folinic acid (or calcium levofolinate), and panitumumab. The second combination includes some of the same medications but without irinotecan. These medications are types of chemotherapy drugs, with panitumumab being a targeted therapy that specifically fights cancer cells.

The main purpose of this study is to evaluate how well patients respond to these treatment combinations, specifically looking at whether the cancer completely disappears after treatment. The study will monitor patients’ responses through regular medical imaging and blood tests to track the effectiveness of the treatments. Patients will receive up to 12 rounds of treatment, with regular check-ups to monitor their health and the cancer’s response to therapy.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups for metastatic colorectal cancer

Your treatment will be based on the results of a blood test that checks for specific genetic markers (RAS and B-RAF)

2a Treatment administration – Group 1

If assigned to group 1, you will receive FOLFIRINOX plus panitumumab

The treatment includes infusions of: oxaliplatin, irinotecan, panitumumab, folinic acid, and fluorouracil

Treatments will be given in cycles for up to 12 cycles total

2b Treatment administration – Group 2

If assigned to group 2, you will receive mFOLFOX6 plus panitumumab

The treatment includes infusions of: oxaliplatin, panitumumab, folinic acid, and fluorouracil

Treatments will be given in cycles for up to 12 cycles total

3 Monitoring during treatment

Regular medical examinations will check your response to treatment

Imaging scans (CT or MRI) will be performed to measure tumor response

Blood tests will monitor your health status

Side effects will be monitored and recorded throughout treatment

4 Response evaluation

Your response to treatment will be evaluated after 4 cycles to measure early tumor changes

Complete response will be confirmed by additional scans 4 to 6 weeks after treatment completion

If your cancer becomes operable during treatment, surgery may be considered

5 Follow-up period

After completing treatment, regular follow-up visits will continue

Your health status will be monitored until 2028

Long-term effects and survival will be tracked throughout the follow-up period

Who Can Join the Study?

Age must be between 18 and 75 years
Must have active social security coverage
Must provide informed consent by signing the written consent form
Blood uracil levels must be less than 16 ng/ml
Must have good physical performance status (ECOG score of 0 or 1, meaning able to perform daily activities with minimal limitations)
Must have confirmed colon or rectal cancer through tissue examination (adenocarcinoma)
Must have metastatic disease (cancer that has spread) that cannot be removed by surgery
Must have specific genetic characteristics: normal (wild-type) versions of genes called K-Ras, N-Ras, and B-Raf, as determined by blood testing
Must have cancer that can be measured using standard imaging methods
Must have adequate blood test results including:
- White blood cell count above 2,000/mm³
- Hemoglobin above 9 g/dL
- Platelet count above 100,000/mm³
- Liver function tests within specified limits
- Kidney function showing clearance above 50 mL/min
Must have life expectancy of at least 3 months
Must use appropriate birth control if applicable

Who Cannot Join the Study?

Prior treatment with FOLFIRINOX chemotherapy or panitumumab therapy
Known mutations in RAS or B-RAF genes confirmed by blood test
Active brain metastases (cancer spread to the brain)
History of other cancers within the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
Severe heart conditions including heart failure, unstable angina, or heart attack within 6 months
Uncontrolled high blood pressure
Serious infections requiring antibiotics
Major surgery within 4 weeks before starting the study
Pregnant or breastfeeding women
Known allergic reactions to study medications
Severe kidney or liver dysfunction
Current participation in other clinical trials
Any condition that could interfere with study procedures or patient safety
Unable to provide informed consent
Mental conditions that prevent understanding of study requirements

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
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre De Cancerologue Du Grand Montpellier	Montpellier	France
Institut Godinot	Reims	France
Centre Hospitalier De Perpignan	Perpignan	France
Hopital Europeen Marseille	Marseille	France
Centre Catalan D’oncologie	Perpignan	France
Hopital Prive Jean Mermoz	Lyon	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hopital Prive Des Cotes D’armor	Plerin	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
L’Hopital Prive Du Confluent	Nantes	France
Groupement Des Hopitaux De L’Institut Catholique De Lille	lomme	France
Ioonszlt Rqpbesag Dy Cgegch Dc Mgngoptbxyu	Montpellier	France
Cezfin Lkhq Bbgjxt	Lyon	France
Cifdrr Hjqmtfxrzdr Unzkendpgkumd Rpame	Reims	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	28.06.2017

Trial locations

Investigated drugs:

Panitumumab is a targeted therapy medication that works by blocking a specific protein called EGFR on cancer cells. It’s used to treat colorectal cancer by helping to stop cancer cells from growing and spreading.

FOLFIRINOX is a combination chemotherapy treatment that includes three different cancer-fighting drugs: fluorouracil, irinotecan, and oxaliplatin. This combination works together to kill cancer cells and prevent them from multiplying.

mFOLFOX6 is a modified combination chemotherapy treatment that includes fluorouracil, leucovorin, and oxaliplatin. This combination is commonly used to treat colorectal cancer by attacking cancer cells in different ways to stop their growth and spread.

Metastatic Colorectal Cancer – A condition where cancer that begins in the colon or rectum spreads to other parts of the body. It develops from abnormal cells in the inner lining of the colon or rectum that grow and multiply uncontrollably. The cancer cells can break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in other organs, most commonly the liver and lungs. In RAS and B-RAF wild-type cases, the cancer cells have normal (non-mutated) versions of these specific genes, which can influence how the disease develops and responds to treatment. This type of colorectal cancer typically begins as small growths called polyps that develop into cancerous tumors over time.

Trial ID:

2024-510645-34-00

Protocol code:

UC-0110/1608

NCT ID:

NCT02980510

Trial Phase:

Therapeutic exploratory (Phase II)

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Comparing drug combinations with panitumumab for patients with RAS and B-RAF wild-type metastatic colorectal cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?