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Study comparing cetuximab with chemotherapy versus bevacizumab with chemotherapy in patients with advanced colorectal cancer who have wild-type RAS and right-sided tumors

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What is this study about?

This clinical trial focuses on patients with advanced colorectal cancer who have specific genetic characteristics (wild-type RAS) and tumors located on the right side of the colon. The study aims to determine whether combining chemotherapy with cetuximab (a targeted therapy) is more effective than chemotherapy with or without bevacizumab (a drug that blocks blood vessel growth in tumors).

The treatment plan includes several chemotherapy medications: irinotecan, oxaliplatin, fluorouracil, folinic acid, and capecitabine. These medications will be given either through an intravenous line directly into the bloodstream or, in some cases, as tablets taken by mouth. The treatment duration may last up to 12 months, depending on how well patients respond to the therapy.

The study will measure how quickly and effectively the tumors shrink after 8 weeks of treatment. Doctors will use regular imaging scans to monitor the size of tumors and track how patients respond to the treatment. The study will also track how long patients live after starting the treatment and monitor any side effects that may occur during therapy.

1 Initial medical assessment

A medical evaluation will confirm your eligibility for the trial based on specific criteria, including age (must be 18 or older) and having advanced colorectal cancer in the right side of the colon

Laboratory tests will be performed to check blood count, liver function, and kidney function

A CT scan will be done to measure your tumors

2 Treatment assignment

You will be randomly assigned to one of two treatment groups

Group 1 will receive chemotherapy with cetuximab

Group 2 will receive chemotherapy with or without bevacizumab

3 Treatment period – First 8 weeks

You will receive treatment through intravenous infusions

The medications used may include combinations of irinotecan, folinic acid, oxaliplatin, fluorouracil, and either cetuximab or bevacizumab

Some medications may be given orally (capecitabine)

4 First evaluation

After 8 weeks, you will have a CT scan to measure how your tumors have responded to treatment

You will complete quality of life questionnaires

5 Continued treatment and monitoring

Treatment will continue with regular evaluations every 8 weeks

CT scans will be performed every 8 weeks to monitor your response to treatment

Additional quality of life assessments will be conducted at 16 weeks, 12 months, and 24 months

6 Safety monitoring

Throughout the trial, you will be monitored for any side effects

Blood tests will be performed regularly to ensure safety

Any adverse effects will be recorded and managed according to standardized criteria

Who Can Join the Study?

  • Must be 18 years or older
  • Must have high levels of specific tumor markers (EREG/AREG) confirmed by central testing
  • Tumor must be measurable on CT scan (or MRI if CT contrast cannot be used)
  • Blood test results must show:
    – Normal white blood cell count (neutrophils ≥1.5)
    – Normal platelet count (≥100)
    – Acceptable liver function tests
    – Adequate kidney function
  • Must have good general health status (WHO performance status of 0, 1, or 2)
  • Must be able to receive combination chemotherapy and targeted therapy (anti-EGFR treatment)
  • Must have a life expectancy of at least 12 weeks
  • Women who can become pregnant must have a negative pregnancy test
  • Must use appropriate birth control methods if sexually active
  • Must provide written informed consent
  • Must have confirmed adenocarcinoma (type of cancer) in the right side of the colon
  • Cancer must be either spread (metastatic) or unable to be surgically removed
  • Tumor must have normal (wild-type) RAS gene status
  • Must have enough tumor tissue available for testing
  • Must be registered in the ARIEL-ENGIC study

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Previous treatment with chemotherapy for advanced colorectal cancer
  • Known RAS gene mutations (changes in genes that affect how cancer cells grow)
  • Left-sided primary tumor location
  • Active brain metastases (cancer that has 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
  • Serious heart conditions, including:
    • Heart attack within the past 6 months
    • Unstable heart disease
    • Uncontrolled high blood pressure
  • Severe kidney or liver dysfunction
  • Known allergies to any of the study medications
  • Pregnancy or breastfeeding
  • Inability to give informed consent
  • Participation in another clinical trial within the past 30 days

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario De Navarra Pamplona Spain
Azienda Usl Toscana Nord Ovest-Ospedale Civile di Livorno Leghorn Italy
Hospital Universitario De Salamanca Salamanca Spain
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Ospedale San Raffaele S.r.l. Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital General Universitario De Valencia Valencia Spain
Muenchen Klinik gGmbH Munich Germany
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
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Iacheiwg Rtawzmwjs Pnm La Ssahgt Dil Thkxrt Doru Abvnezw Ipdg Syzgtk Meldola Italy
Hennyoya Dn Lp Sbsxz Cjwk I Sqhn Pra Barcelona Spain
Invyia Ihjkzanu Faacqoodvqkbv Ofehbnwaohr Rome Italy
Htkpzayf Uiqxxuuwgshrb Hpfucupe Tsboz y Pfjgld Ieqyefee Cwuftj dsshvfwyxdlzxpbwe (rlyp Badalona Spain
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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
Germany Germany
Not yet recruiting
15.10.2025
Italy Italy
Not yet recruiting
15.10.2025
Spain Spain
Not yet recruiting
15.10.2025

Trial locations

Investigated drugs:

Cetuximab
This is a targeted therapy medication that works by blocking a protein called EGFR (Epidermal Growth Factor Receptor) on cancer cells. It is used to treat colorectal cancer by helping to stop cancer cells from growing and spreading.

Bevacizumab
This is a medication that works by blocking the formation of new blood vessels that feed tumors. By preventing the tumor from developing its own blood supply, it helps slow down or stop cancer growth. It is commonly used in combination with other chemotherapy medications to treat colorectal cancer.

Chemotherapy (doublet or triplet)
This refers to combinations of standard chemotherapy medications used to treat colorectal cancer. A doublet means two different chemotherapy drugs are used together, while a triplet means three different chemotherapy drugs are combined in the treatment.

Investigated diseases:

Colorectal Cancer – A cancer that begins in the large intestine (colon) or rectum, specifically affecting the right side of the colon in this context. The disease develops when healthy cells in the colon begin to change and grow out of control, forming a mass called a tumor. It typically starts as small, benign clumps of cells called polyps that over time can become cancerous. In advanced stages, the cancer has spread beyond its original location to other parts of the body. This particular type is characterized by having wild-type RAS genes, meaning they are not mutated, and specifically occurs in the right portion of the colon, which includes the cecum, ascending colon, and transverse colon.

Trial ID:
2025-521209-42-00
Protocol code:
ARIEL-ENGIC
Trial Phase:
Therapeutic confirmatory (Phase III)

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